Flower Suture Anchor Set
Device Facts
| Record ID | K192949 |
|---|---|
| Device Name | Flower Suture Anchor Set |
| Applicant | Flower Orthopedics Corporation |
| Product Code | MBI · Orthopedic |
| Decision Date | Oct 7, 2020 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 888.3040 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The Flower Suture Anchor Set is intended to be used to aid arthroscopic and orthopedic reconstructive procedures needing soft tissue fixation, due to injury or degenerative disease.
Device Story
Flower Suture Anchor Set comprises PEEK screw-like anchors pre-loaded with UHMWPE non-absorbable sutures and inserters. Used in arthroscopic and orthopedic reconstructive surgeries to secure soft tissue to bone. Operated by surgeons in clinical settings (OR). Anchors are implanted into bone to provide mechanical fixation for reattaching soft tissue. Benefits include restoration of anatomical integrity following injury or degenerative disease. Supplied sterile, single-use, ready-for-surgery.
Clinical Evidence
Bench testing only. Performance evaluated per FDA Draft Guidance for Testing Bone Anchor Devices, including insertion, pull-out, and fatigue testing. Biocompatibility testing performed per ISO 10993-1, -5, and -7. Sterilization validated per ISO 11135-1 and ISO 11137. No clinical data presented.
Technological Characteristics
Materials: PEEK (anchors), UHMWPE (sutures). Principle: Mechanical screw-in fixation. Dimensions: 3.0mm, 5.0mm diameters; 10mm, 17mm lengths. Sterilization: Ethylene oxide (anchors/inserters), gamma radiation (taps/drill bits). Standards: USP 41-NF36 (sutures), ISO 10993 (biocompatibility), ISO 11135/11137 (sterilization), ANSI/AAMI ST72 (endotoxins).
Indications for Use
Indicated for soft tissue reattachment in shoulder, elbow, wrist/hand, foot/ankle, and knee. Specific procedures include Bankart, rotator cuff, SLAP lesion, capsule/capsulolabral, acromio-clavicular, deltoid, biceps tenodesis, scapholunate ligament, tendon repair/reconstruction, hallux valgus, lateral/medial stabilization, mid/forefoot, biceps tendon, ulnar/radial collateral ligament, lateral epicondylitis, patellar ligament/tendon, iliotibial band tenodesis, joint capsule closure, extracapsular repair, and VMO advancement.
Regulatory Classification
Identification
A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.
Predicate Devices
- Rog Suture Anchor (K113299)
- Arthrex 3.0mm SutureTak (K061863)
- Rog Suture Anchor 5.5mm, 2.9mm (K110229)
- Rog Knotless Suture Anchor (K110230)
- Rog Suture Anchor, Rog Knotless Suture Anchor (K111590)
- Modified Rog Suture Anchor (K112991)
Submission Summary (Full Text)
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October 7, 2020
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Flower Orthopedics Corporation Amanda Pentecost, Ph.D. RA/QA Engineer Flower Orthopedics Corp. 3973 Delp Street Memphis, Tennessee 38118
Re: K192949
Trade/Device Name: Flower Suture Anchor Set Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: MBI Dated: September 10, 2020 Received: September 11, 2020
Dear Dr. Pentecost:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for
Laura Rose, Ph.D. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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# Indications for Use
510(k) Number (if known) K192949
Device Name Flower Suture Anchor Set
#### Indications for Use (Describe)
The Flower Suture Anchor Set is intended to be used to aid arthroscopic and orthopedic reconstructive procedures needing soft tissue fixation, due to injury or degenerative disease.
The FlowerAnchor. 3.0mm is indicated for use in soft tissue reattachment procedures in the shoulder, elbow, wristhand. foot/ankle and knee. Specific indications are as follows:
· Shoulder indications: Bankart repair, rotator cuff repair, capsule repair, capsule repair or capsulolabral reconstruction, acromio-clavicular separation, deltoid repair, biceps tenodesis.
- · Wrist/hand indications: Scapholunate ligament reconstruction.
· Foot/Ankle indications: Tendon repair/reconstruction, hallux valgus reconstruction, lateral stabilization, medial stabilization, mid- and forefoot reconstructions.
- · Elbow indications: Biceps tendon reconstruction, ulnar or radial collateral ligament reconstruction.
• Knee indications: Lateral collateral ligament repair, medial collateral ligament repair, posterior oblique ligament repair, patellar ligament/tendon repair, iliotibial band tenodesis, joint capsule closure, extracapsular repair, vastus medialis obliquus (VMO) muscle advancement.
The FlowerAnchor, 5.0mm and FlowerAnchor, Knotless is indicated for soft tissue reattachment procedures in the shoulder, elbow, wrist/hand, foot/ankle and knee. Specific indications are as follows:
• Shoulder indications: Bankart repair, rotator cuff repair, capsule repair, capsule repair or capsulolabral reconstruction, acromio-clavicular separation,deltoid repair, biceps tenodesis.
- Wrist/hand indications: Ulnar/Radial collateral ligament reconstruction, scapholunate ligament reconstruction.
· Foot/Ankle indications: Achilles tendon repair/reconstruction, hallux valgus reconstruction, lateral stabilization, medial stabilization, mid- and forefoot reconstructions.
· Elbow indications: Biceps tendon reconstruction, ulnar or radial collateral ligament reconstruction, lateral epicondylitis repair.
• Knee indications: Lateral collateral ligament repair, medial collateral ligament repair, posterior oblique ligament repair, patellar ligament/tendon repair, iliotibial band tenodesis, joint capsule closure.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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#### K192949 510(k) Summary Flower Suture Anchor Set
### Submitter: Flower Orthopedics Corporation
100 Witmer Rd. Suite 280 Horsham PA, 19044
Phone: 215-394-8903 Facsimile: 215-394-8904
Contact Person: Amanda Pentecost, Ph.D. Date Prepared: September 29, 2020
#### Name of Device:
Flower Suture Anchor Set
Trade Name: Flower Suture Anchor Set
Common Name: Suture Anchor
Classification: Fastener, Fixation, Nondegradable, Soft Tissue (Product Code: MBI), Class II, Orthopedic Review Panel, 21 C.F.R. 888.3040
#### Predicate Devices:
| Manufacturer | Trade Name | 510K |
|--------------------------|--------------------------------------------------|---------|
| Primary Predicate: | | |
| RoG Sports Medicine Inc. | Rog Suture Anchor | K113299 |
| Additional Predicates: | | |
| Arthrex, Inc. | Arthrex 3.0mm SutureTak | K061863 |
| RoG Sports Medicine Inc. | Rog Suture Anchor 5.5mm, 2.9mm | K110229 |
| RoG Sports Medicine Inc. | Rog Knotless Suture Anchor | K110230 |
| RoG Sports Medicine Inc. | Rog Suture Anchor, Rog Knotless Suture<br>Anchor | K111590 |
| RoG Sports Medicine Inc. | Modified Rog Suture Anchor | K112991 |
## Device Description
The Flower Suture Anchor Set consists of FlowerAnchor, 3.0mm, FlowerAnchor, 5.0mm, and FlowerAnchor, Knotless with lengths of 10mm and 17mm, respectively. The anchors are screw-like in shape and made of PEEK. The anchors are threaded with ultra-high molecular weight polyethylene (UHMWPE) non-absorbable sutures. The 3.0mm and 5.0mm anchors, USP Size 0 and Size 2 sutures, and inserters and the Knotless anchor and inserter are supplied as a single assembly, sterilized by ethylene-oxide, nonpyrogenic, and ready-for-surgery.
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Accessories of Taps and Drill Bit Kits are supplied sterile by means of gamma radiation with the Flower Suture Anchor Set.
#### Intended Use / Indications for Use
The Flower Suture Anchor Set is intended to be used to aid arthroscopic and orthopedic reconstructive procedures needing soft tissue fixation, due to injury or degenerative disease,
The FlowerAnchor, 3.0mm is indicated for use in soft tissue reattachment procedures in the shoulder, elbow, wrist/hand, foot/ankle and knee. Specific indications are as follows:
- Shoulder indications: Bankart repair, rotator cuff repair, SLAP lesion repair, capsule repair or capsulolabral reconstruction, acromio-clavicular separation, deltoid repair, biceps tenodesis,
- Wrist/hand indications: Scapholunate ligament reconstruction.
- · Foot/Ankle indications: Tendon repair/reconstruction, hallux valgus reconstruction, lateral stabilization, medial stabilization, mid- and forefoot reconstructions.
- · Elbow indications: Biceps tendon reconstruction, ulnar or radial collateral ligament reconstruction.
- Knee indications: Lateral collateral ligament repair, medial collateral ligament repair, posterior oblique ligament repair, patellar ligament/tendon repair, iliotibial band tenodesis, joint capsule closure, extracapsular repair, vastus medialis obliquus (VMO) muscle advancement.
The FlowerAnchor, 5.0mm and FlowerAnchor, Knotless is indicated for soft tissue reattachment procedures in the shoulder, elbow, wrist/hand, foot/ankle and knee. Specific indications are as follows:
- Shoulder indications: Bankart repair, rotator cuff repair, SLAP lesion repair,capsule repair or capsulolabral reconstruction, acromio-clavicular separation, deltoid repair, biceps tenodesis.
- Wrist/hand indications: Ulnar/Radial collateral ligament reconstruction, scapholunate ligament reconstruction.
- · Foot/Ankle indications: Achilles tendon repair/reconstruction, hallux valgus reconstruction, lateral stabilization, medial stabilization, mid- and forefoot reconstructions.
- · Elbow indications: Biceps tendon reconstruction, ulnar or radial collateral ligament reconstruction, lateral epicondylitis repair.
- Knee indications: Lateral collateral ligament repair, medial collateral ligament repair, posterior oblique ligament repair, patellar ligament/tendon repair, iliotibial band tenodesis, joint capsule closure.
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| Device | Subject Device<br>Flower Suture<br>Anchor Set | Primary Predicate<br>Rog Suture<br>Anchor | Arthrex 3.0mm<br>SutureTak | Rog Suture Anchor<br>5.5mm, 2.9mm | Rog Knotless<br>Suture Anchor | Rog Suture Anchor,<br>Rog Knotless Suture<br>Anchor | Modified Rog Suture<br>Anchor |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k)# | K192949 | K113299 | K061863 | K110229 | K110230 | K111590 | K112991 |
| Intended Use | Secure soft tissue to<br>bone | Secure soft tissue to<br>bone | Secure soft tissue<br>to bone | Secure soft tissue<br>to bone | Secure soft tissue to<br>bone | Secure soft tissue to<br>bone | Secure soft tissue to<br>bone |
| Indications for<br>Use | The FlowerAnchor,<br>5.0mm and<br>FlowerAnchor,<br>Knotless is indicated<br>for soft tissue<br>reattachment<br>procedures in the<br>shoulder, elbow,<br>wrist/hand,<br>foot/ankle and knee.<br>Specific indications<br>are as follows:<br>Shoulder<br>indications:<br>Bankart repair,<br>rotator cuff repair,<br>SLAP lesion<br>repair, capsule repair<br>or capsulolabral<br>reconstruction,<br>acromio-clavicular<br>separation, deltoid<br>repair, biceps<br>tenodesis.<br>Wrist/hand<br>indications:<br>Ulnar/Radial<br>collateral ligament<br>reconstruction,<br>scapholunate<br>ligament<br>reconstruction.<br>Foot/Ankle<br>indications: | The RoGTM 5.5 mm<br>Suture Anchor is<br>indicated for soft<br>tissue reattachment<br>procedures in the<br>shoulder, elbow,<br>wrist/hand,<br>foot/ankle and knee.<br>Specific indications<br>are as follows:<br>Shoulder<br>indications:<br>Bankart repair,<br>rotator cuff repair,<br>SLAP lesion repair,<br>capsule repair or<br>capsulolabral<br>reconstruction,<br>acromio-clavicular<br>separation, deltoid<br>repair, biceps<br>tenodesis.<br>Wrist/hand<br>indications:<br>Ulnar/Radial<br>collateral ligament<br>reconstruction,<br>scapholunate<br>ligament<br>reconstruction.<br>Foot/ankle<br>indications:<br>Achilles tendon<br>repair/reconstruction<br>, hallax valgus<br>reconstruction,<br>lateral stabilization,<br>medial stabilizati | The Arthrex<br>Corkscrew Family<br>of Suture Anchors<br>has been<br>previously cleared<br>in 510(k) K003817,<br>K003227,<br>K043337, and<br>K050358. These<br>suture anchors are<br>intended for<br>fixation of<br>suture(soft tissue)<br>to bone in the<br>shoulder,<br>foot/ankle, hip,<br>knee, hand/wrist,<br>elbow, and pelvis<br>in, but not limited<br>to, the following<br>procedures:<br>Shoulder: Rotator<br>Cuff Repairs,<br>Bankart Repair,<br>SLAP Lesion<br>Repair, Biceps<br>Tenodesis,<br>Acromio-Clavicular<br>Separation Repair,<br>Deltoid Repair,<br>Capsular Shift or<br>Capsulolabral<br>Reconstruction.<br>Foot/Ankle:<br>Lateral<br>Stabilization,<br>Medial<br>Stabilization | The RoG 5.5 mm<br>Suture Anchor is<br>indicated for soft<br>tissue<br>reattachment<br>procedures in the<br>shoulder, elbow,<br>wrist/hand,<br>foot/ankle and<br>knee. Specific<br>indications are as<br>follows: Shoulder<br>indications:<br>Bankart repair,<br>rotator cuff repair,<br>SLAP lesion<br>repair, capsule<br>repair or<br>capsulolabral<br>reconstruction,<br>acromio-clavicular<br>separation, deltoid<br>repair, biceps<br>tenodesis.<br>Wrist/hand<br>indications:<br>Ulnar/Radial<br>collateral ligament<br>reconstruction,<br>scapholunate<br>ligament<br>reconstruction.<br>Foot/Ankle<br>indications:<br>Achilles tendon<br>repair/reconstructi<br>on, hallax valgus<br>atruatio | The RoG 5.5mm<br>Knotless Suture<br>Anchor is indicated<br>for soft tissue<br>reattachment<br>procedures in the<br>shoulder, elbow,<br>wrist/hand,<br>foottankle and knee.<br>Specific indications<br>are as follows:<br>Shoulder<br>indications:<br>Bankart repair,<br>rotator cuff repair,<br>SLAP lesion repair,<br>capsule repair or<br>capsulolabral<br>reconstruction,<br>acromio-clavicular<br>separation, deltoid<br>repair, biceps<br>tenodesis-<br>Wrist/Hand<br>indications:<br>Ulnar/Radial<br>collateral ligament<br>reconstruction,<br>scapholunate<br>ligament<br>reconstruction.<br>Foot/Ankle<br>indications:<br>Achilles tendon<br>repair/reconstruction<br>, hallax valgus<br>reconstruction,<br>Lateral stabilizati | The RoG 5.5 mm<br>Suture Anchor is<br>indicated for soft<br>tissue reattachment<br>procedures in the<br>shoulder, elbow,<br>wrist/hand,<br>foot/ankle and knee.<br>Specific indications<br>are as follows:<br>Shoulder<br>indications:<br>Bankart repair,<br>rotator cuff repair,<br>SLAP lesion repair,<br>capsule repair or<br>capsulolabral<br>reconstruction,<br>acromio-clavicular<br>separation, deltoid<br>repair, biceps<br>tenodesis.<br>Wrist/hand<br>indications:<br>Ulnar/Radial<br>collateral ligament<br>reconstruction,<br>scapholunate<br>ligament<br>reconstruction.<br>Foot/Ankle<br>indications:<br>Achilles tendon<br>repair/reconstruction<br>, hallax valgus<br>reconstruction,<br>lateral stabilization, | The RoG 5.5 mm<br>Suture Anchor is<br>indicated for soft<br>tissue reattachment<br>procedures in the<br>shoulder, elbow,<br>wrist/hand,<br>foot/ankle and knee<br>Specific indications<br>are as follows:<br>Shoulder<br>indications:<br>Bankart repair,<br>rotator cuff repair,<br>SLAP lesion repair,<br>capsule repair or<br>capsulolabral<br>reconstruction,<br>acromio-clavicular<br>separation, deltoid<br>repair, biceps<br>tenodesis.<br>Wrist/hand<br>indications:<br>Ulnar/Radial<br>collateral ligament<br>reconstruction,<br>scapholunate<br>ligament<br>reconstruction.<br>Foot/Ankle<br>indications:<br>Achilles tendon<br>repair/reconstructio<br>, hallax valgus<br>reconstruction,<br>lateral stabilization,<br>modial otobilization |
| , hallux valgus<br>reconstruction,<br>lateral stabilization,<br>medial stabilization,<br>mid- and forefoot<br>reconstructions. | reconstructions.<br>Elbow indications:<br>Biceps tendon<br>reconstruction, ulnar<br>or radial collateral<br>ligament<br>reconstruction,<br>lateral epicondylitis<br>repair.<br>Knee indications:<br>Lateral collateral<br>ligament repair,<br>medial collateral<br>ligament repair,<br>posterior oblique<br>ligament repair,<br>patellar<br>ligament/tendon<br>repair, iliotibial band<br>tenodesis, joint<br>capsule closure. | Repair, Hallux<br>Valgus<br>Reconstruction,<br>Midfoot<br>Reconstruction,<br>Metatarsal<br>Ligament [Tendon<br>Repair],<br>Bunionectomy.<br>Knee: Anterior<br>Cruciate Ligament<br>Repair, Medial<br>Collateral<br>Ligament Repair,<br>Lateral Collateral<br>Ligament Repair,<br>Patellar Tendon<br>Repair, Posterior<br>Oblique Ligament<br>Repair, and<br>Iliotibial Band<br>Tenodesis.<br>Hand/Wrist:<br>Scapholunate<br>Ligament<br>Reconstruction,<br>Ulnar Collateral<br>Ligament<br>Reconstruction,<br>Radial Collateral<br>Ligament<br>Reconstruction.<br>Elbow: Biceps<br>Tendon<br>Reattachment,<br>Tennis Elbow<br>Repair, Ulnar or<br>Radial Collateral<br>Ligament<br>Reconstruction,<br>Lateral<br>Epicondylitis<br>repair. Pelvis:<br>Bladder Neck<br>Suspension for<br>female urinary<br>incontinence due<br>to urethral<br>hypermobility of<br>intrinsic sphincter | stabilization,<br>medial<br>stabilization, mid-<br>and forefoot<br>reconstructions.<br>Elbow<br>indications:<br>Biceps tendon<br>reconstruction,<br>ulnar or radial<br>collateral ligament<br>reconstruction,<br>lateral<br>epicondylitis<br>repair.<br>Knee indications:<br>Lateral collateral<br>ligament repair,<br>medial collateral<br>ligament repair,<br>posterior oblique<br>ligament repair,<br>patellar<br>ligament/tendon<br>repair. Iliotibial<br>band tenodesis,<br>joint capsule<br>closure. | mid- and forefoot<br>reconstructions.<br>Elbow indications:<br>Biceps tendon<br>reconstruction, ulnar<br>or radial collateral<br>ligament<br>reconstruction,<br>lateral epicondylitis<br>repair.<br>Knee indications:<br>Lateral collateral<br>ligament repair,<br>medial collateral<br>ligament repair,<br>posterior oblique<br>ligament repair,<br>patellar<br>ligament/tendon<br>repair. Iliotibial band<br>tenodesis, joint<br>capsule closure. | reconstructions.<br>Elbow indications:<br>Biceps tendon<br>reconstruction, ulnar<br>or radial collateral<br>ligament<br>reconstruction,<br>lateral epicondylitis<br>repair.<br>Knee indications:<br>Lateral collateral<br>ligament repair,<br>medial collateral<br>ligament repair,<br>posterior oblique<br>ligament repair,<br>patellar<br>ligament/tendon<br>repair. Iliotibial<br>band tenodesis,<br>joint capsule<br>closure. | reconstructions.<br>Elbow indications:<br>Biceps tendon<br>reconstruction, ulnar<br>or radial collateral<br>ligament<br>reconstruction,<br>lateral epicondylitis<br>repair.<br>Knee indications:<br>Lateral collateral<br>ligament repair,<br>medial collateral<br>ligament repair,<br>posterior oblique<br>ligament repair,<br>patellar<br>ligament/tendon<br>repair. Iliotibial band<br>tenodesis, joint<br>capsule closure.<br>The RoG 2.9mm<br>Suture Anchor is<br>indicated for use in<br>soft tissue<br>reattachment<br>procedures. Specific<br>indications are as<br>follows:<br>Shoulder<br>indications:<br>Bankart repair,<br>rotator cuff repair,<br>SLAP lesion repair,<br>capsule repair or<br>capsulolabral<br>reconstruction,<br>acromio-clavicular<br>separation, deltoid<br>repair, biceps<br>tenodesis.<br>Wrist/hand<br>indications:<br>Scapholunate<br>ligament<br>reconstruction.<br>Elbow indications:<br>Biceps tendon<br>reconstruction ulnar | |
| The FlowerAnchor,<br>3.0mm is indicated<br>for use in soft tissue<br>reattachment<br>procedures in the<br>shoulder, elbow,<br>wrist/hand,<br>foot/ankle and knee.<br>Specific indications<br>are as follows:<br>Shoulder<br>indications:<br>Bankart repair,<br>rotator cuff repair,<br>SLAP lesion repair,<br>capsule repair or<br>capsulolabral<br>reconstruction, | The RoGTM 2.9mm<br>Suture Anchor is<br>indicated for use in<br>soft tissue<br>reattachment<br>procedures. Specific<br>indications are as<br>follows:<br>Shoulder<br>indications:<br>Bankart repair,<br>rotator cuff repair,<br>SLAP lesion repair,<br>capsule repair or<br>capsulolabral<br>reconstruction,<br>acromio-clavicular<br>separation, deltoid<br>repair, biceps<br>tenodesis.<br>Wrist/hand<br>indications:<br>Scapholunate<br>ligament<br>reconstruction.<br>Elbow indications:<br>Biceps tendon<br>reconstruction ulnar | The RoG 2.9mm<br>Suture Anchor is<br>indicated for use<br>in soft tissue<br>reattachment<br>procedures.<br>Specific<br>indications are as<br>follows:<br>Shoulder<br>indications:<br>Bankart repair,<br>rotator cuff repair,<br>SLAP lesion<br>repair, capsule<br>repair or<br>capsulolabral<br>reconstruction,<br>acromio-clavicular<br>separation, deltoid<br>repair biceps | The RoG 2.9mm<br>Suture Anchor is<br>indicated for use in<br>soft tissue<br>reattachment<br>procedures. Specific<br>indications are as<br>follows:<br>Shoulder<br>indications:<br>Bankart repair,<br>rotator cuff repair,<br>SLAP lesion repair,<br>capsule repair or<br>capsulolabral<br>reconstruction,<br>acromio-clavicular<br>separation, deltoid<br>repair, biceps<br>tenodesis.<br>Wrist/hand<br>indications:<br>Scapholunate<br>ligament<br>reconstruction.<br>Elbow indications:<br>Biceps tendon | The RoG 2.9mm<br>Suture Anchor is<br>indicated for use in<br>soft tissue<br>reattachment<br>procedures. Specific<br>indications are as<br>follows:<br>Shoulder<br>indications:<br>Bankart repair,<br>rotator cuff repair,<br>SLAP lesion repair,<br>capsule repair or<br>capsulolabral<br>reconstruction,<br>acromio-clavicular<br>separation, deltoid<br>repair, biceps<br>tenodesis.<br>Wrist/hand<br>indications:<br>Scapholunate<br>ligament<br>reconstruction.<br>Elbow indications:<br>Biceps tendon<br>reconstruction ulnar | | | |
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| acromio-clavicular<br>separation, deltoid<br>repair, biceps<br>tenodesis.<br><b>Wrist/hand<br/>indications:</b><br>Scapholunate<br>ligament<br>reconstruction.<br><b>Foot/Ankle<br/>indications:</b><br>Tendon<br>repair/reconstruction<br>, hallux valgus<br>reconstruction,<br>lateral stabilization,<br>medial stabilization,<br>mid- and forefoot<br>reconstructions.<br><b>Elbow indications:</b><br>Biceps tendon<br>reconstruction, ulnar<br>or radial collateral<br>ligament<br>reconstruction.<br><b>Knee indications:</b><br>Lateral collateral<br>ligament repair,<br>medial collateral<br>ligament repair,<br>posterior oblique<br>ligament repair,<br>patellar<br>ligament/tendon<br>repair, iliotibial band<br>tenodesis, joint<br>capsule closure,<br>extracapsular repair,<br>vastus medialis<br>obliquus (VMO)<br>muscle<br>advancement. | or radial collateral<br>ligament<br>reconstruction.<br><b>Knee indications:</b><br>Lateral collateral<br>ligament repair,<br>medial collateral<br>ligament repair,<br>posterior oblique<br>ligament repair,<br>patellar<br>ligament/tendon<br>repair, iliotibial band<br>tenodesis, joint<br>capsule closure,<br>extracapsular repair,<br>vastus medialis<br>obliquus (VMO)<br>muscle<br>advancement.<br>The RoGTM 5.5 mm<br>Knotless Suture<br>Anchor is indicated<br>for soft tissue<br>reattachment<br>procedures in the<br>shoulder, elbow,<br>wrist/hand,<br>foot/ankle and knee.<br>Specific indications<br>are as follows:<br><b>Shoulder<br/>indications:</b><br>Bankart repair,<br>rotator cuff repair,<br>SLAP lesion repair,<br>capsule repair or<br>capsulolabral<br>reconstruction,<br>acromio-clavicular<br>separation, deltoid<br>repair, biceps<br>tenodesis.<br><b>Wrist/hand<br/>indications:</b><br>Ulnar/Radial<br>collateral ligament<br>reconstruction,<br>scapholunate | deficiency. Hip:<br>Capsular repair,<br>acetabular labral<br>repair. | tenodesis.<br><b>Wrist/hand<br/>indications:</b><br>Scapholunate<br>ligament<br>reconstruction.<br><b>Elbow<br/>indications:</b><br>Biceps tendon<br>reconstruction,<br>ulnar or radial<br>collateral ligament<br>reconstruction.<br><b>Knee indications:</b><br>Lateral collateral<br>ligament repair,<br>medial collateral<br>ligament repair,<br>posterior oblique<br>ligament repair,<br>patellar<br>ligament/tendon<br>repair. Iliotibial<br>band tenodesis,<br>joint capsule<br>closure.<br>Extracapsular<br>repair, vastus<br>medialis obliquus<br>(VMO) muscle<br>advancement. | reconstruction, ulnar<br>or radial collateral<br>ligament<br>reconstruction.<br><b>Knee indications:</b><br>Lateral collateral<br>ligament repair,<br>medial collateral<br>ligament repair,<br>posterior oblique<br>ligament repair,<br>patellar<br>ligament/tendon<br>repair. Iliotibial band<br>tenodesis, joint<br>capsule closure.<br>Extracapsular repair,<br>vastus medialis<br>obliquus (VMO)<br>muscle<br>advancement. | or radial collateral<br>ligament<br>reconstruction.<br><b>Knee indications:</b><br>Lateral collateral<br>ligament repair,<br>medial collateral<br>ligament repair,<br>posterior oblique<br>ligament repair,<br>patellar<br>ligament/tendon<br>repair. Iliotibial band<br>tenodesis, joint<br>capsule closure.<br>Extracapsular repair<br>vastus medialis<br>obliquus (VMO)<br>muscle<br>advancement. |
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| Classification<br>Name | Fastener, Fixation,<br>Nondegradable,<br>Soft Tissue | Fastener, Fixation,<br>Nondegradable,<br>Soft Tissue | Screw, Fixation,<br>Bone | Fastener, Fixation,<br>Nondegradable,<br>Soft Tissue | Fastener, Fixation,<br>Nondegradable,<br>Soft Tissue | Fastener, Fixation,<br>Nondegradable, Soft<br>Tissue | Fastener, Fixation,<br>Nondegradable, Soft<br>Tissue |
|------------------------|------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------|------------------------------------------------------|------------------------------------------------------|------------------------------------------------------|------------------------------------------------------|
| | | ligament<br>reconstruction.<br><b>Foot/ankle<br/>indications:</b><br>Achilles tendon<br>repair/reconstruction<br>, hallax valgus<br>reconstruction,<br>lateral stabilization,<br>medial stabilization,<br>mid- and forefoot | | | | | |
| | | reconstructions.<br><b>Elbow indications:</b><br>Biceps tendon<br>reconstruction, ulnar<br>or radial collateral<br>ligament<br>reconstruction,<br>lateral epicondylitis<br>repair.<br><b>Knee indications:</b><br>Lateral collateral<br>ligament repair,<br>medial collateral | | | | | |
| | | ligament repair,<br>posterior oblique<br>ligament repair,<br>patellar<br>ligament/tendon<br>repair, iliotibial band<br>tenodesis, joint<br>capsule closure. | | | | | |
| Product Code | MBI | MBI | HWC<br>(JDR, MAI, MBI) | MBI | MBI | MBI | MBI |
| Material | PEEK | PEEK | PEEK | PEEK | PEEK | PEEK | PEEK |
| Sizes | 3.0mm, 5.0mm | 5.5mm, 2.9mm | 3.0mm | 5.5mm, 2.9mm | 5.5mm | 5.5mm, 2.9mm | 5.5mm, 2.9mm |
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## Comparison of Technological Characteristics
Soft tissue reattachment aid using PEEK anchors and non-absorbable suture is the technological principle for both the subject and predicate devices. It is based on the use of one or more PEEK anchors with non-absorbable sutures. At a high level, the subject and predicate devices have the same indication for use and are made from the same materials. The suture is from the same supplier as the primary predicate. Anchors are both made from PEEK. Additionally, both the subject and predicate devices are provided sterile.
There are several technological differences between the subject and predicate devices. The primary predicate device offers a 2.9mm and 5.5mm diameter anchor while Flower Orthopedics Suture Anchor Set offers a 3.0mm and 5.0mm diameter anchor. Thus, the proposed diameters for the Flower Orthopedics Suture Anchor Set is within the range of the predicate devices. Although there are minor differences in dimensions and design, testing of the subject device establishes equivalent mechanical strength of the subject device as compared to the predicate device. The primary predicate device offers a single strand of USP size 2 suture with their 2.9mm anchor while the FlowerAnchor 3.0mm offers two strands of USP size 0 sutures. The sutures have been previously cleared.
## Performance Data
The Flower Suture Anchor Set was tested (worse case) in accordance with FDA's Draft Guidance Document for Testing Bone Anchor Devices. Testing consisted of Insertion, Pull out, and Fatigue in comparison to the predicate devices. The subject device was found to be equivalent to the predicate devices in such performance. Cytotoxicity testing was also separately performed on both the patientcontacting and non-patient-contacting components
Additionally, the Flower Suture Anchor Set was evaluated according to the following standards:
- USP 41-NF36:2018 <861>, Sutures Diameter .
- USP 41-NF36:2018 <871>, Sutures Needle Attachment ●
- USP 41-NF36:2018 <881>, Tensile Strength .
- ISO 10993-1, Biological evaluation of medical devices Part 1: Evaluation and . testing within a risk management process;
- ISO 10993-5, Biological evaluation of medical devices Part 5: Tests for in vitro . cytotoxicity:
- ISO 10993-7, Ethylene oxide sterilization residuals .
- ISO 11135-1, Ethylene Oxide Sterilization .
- ISO 11137, Radiation Sterilization ●
- ANSI/AAMI ST72:2011/ (R)2016, Bacterial Endotoxins Test Methods, Routine ● Monitoring, And Alternatives To Batch Testing
In all instances, the Flower Suture Anchor Set functioned and test results demonstrated substantial equivalence with the cited predicate devices.
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## Conclusions
The Flower Suture Anchor Set is as safe and effective as the identified predicate devices. The subject device has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. The minor differences in the device configuration being packaged with additional sutures and inserters raise no new issues of safety or effectiveness Performance data demonstrate that the subject devices are as safe and effective as the predicate devices. Thus, the Flower Suture Anchor Set is substantially equivalent.
