K041305 · Stryker Endoscopy · MAI · Jun 14, 2004 · Orthopedic
Device Facts
Record ID
K041305
Device Name
STRYKER BIOZIP SUTURE ANCHOR SYSTEM
Applicant
Stryker Endoscopy
Product Code
MAI · Orthopedic
Decision Date
Jun 14, 2004
Decision
SESE
Submission Type
Special
Regulation
21 CFR 888.3030
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
The Styker BioZip Suture Anchor System is intended foruse in maloutions for tissue to bone in such procedures as: Shoulder: Rotator cuff repair Bankart repair SLAP lesion repair Acromio-clavicular sepaeration repair Capsular shift/capsulolabral reconstruction Biceps tenodesis Deltoid repair Knee: Extra capsular repairs Medial collateral ligament Lateral collateral ligament Posterior oblique ligament Illiotibial band tenosis Patellar tendon repair Elbow, Wrist, Hand: Scapholunate ligament reconstruction Ulnar collateral ligament reconstruction radial Collateral ligament reconstruction Biceps tendon reattachment Foot & Ankle Medial instability repair/reconstruction Lateral instability repair/reconstruction Achilles tendon repair/reconstruction Midfoot reconstruction Hallux valgus reconstruction Pelvis: Bladder neck suspension procedures The Stryker BioZip Suture Anchor System is intended for single-use only.
Device Story
Stryker BioZip Suture Anchor System is a line extension of a previously cleared device; used for securing soft tissue to bone. Device consists of a Poly L-lactic acid (PLLA) screw-in anchor pre-threaded with non-absorbable braided polyethylene surgical sutures; pre-assembled on a disposable inserter. Used by surgeons in clinical/OR settings for orthopedic soft tissue repair. Device provides mechanical fixation of tissue to bone; benefits patient by facilitating surgical repair of ligaments and tendons. Provided sterile for single-use.
Clinical Evidence
Bench testing only. Device validated for sterility (SAL 10^-6) per ANSI/AAMI/ISO 11135 and packaging integrity per ASTM 4169. Biocompatibility confirmed per ISO-10993-1 and G95-1.
Indicated for soft tissue to bone fixation in orthopedic procedures including shoulder (rotator cuff, Bankart, SLAP, AC repair, capsular reconstruction, biceps tenodesis, deltoid repair), knee (extra capsular, MCL, LCL, POL, IT band, patellar tendon), elbow/wrist/hand (ligament reconstruction, biceps reattachment), foot/ankle (instability, Achilles, midfoot, hallux valgus), and pelvis (bladder neck suspension). Single-use only.
Regulatory Classification
Identification
Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.
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Image /page/0/Picture/0 description: The image contains a sequence of alphanumeric characters. The characters are 'K', 'O', '4', '1', '3', '0', and '5'. The characters are written in a simple, handwritten style.
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'JUN 1 4 2004
Endoscopy
## SUMMARY OF SAFETY AND EFFECTIVENESS
### Device Name
Classification Name:
Common and Usual Name: Proprietary Name:
Fastener, Fixation, Biodegradable, Soft Tissue 21 CFR §888.3040, Class II Bioabsorbable Suture Anchor Stryker BioZip Suture Anchor System
### Predicate Device
Stryker BioZip Suture Anchor System (#K023192), currently marketed by Stryker Endoscopy (San Jose, CA).
### Summary
This summary of Special 510(k) safety and effectiveness is being submitted in accordance with requirements of SMDA 1990.
The line extension of the Stryker BioZip Suture Anchor System is intended for use in providing a means for securing soft tissue to bone using suture. The line extension of the Stryker BioZip Suture Anchor System consists of a Poly L-lactic acid (PLLA) screw-in type anchor pre-threaded with non-absorbable braided polyethylene surgical sutures, and pre-assembled on a disposable inserter.
The line extension of the Stryker BioZip Suture Anchor System will be provided sterile for single-use (ASTM 4169). The device will be sterilized by Ethylene Oxide (ANSVAAMI/ISO 11135), including limits for Ethylene Oxide residuals and validated to a sterility assurance level (SAL) of 10 °. The device is biocompatible per ISO-10993-1 and G95-1. The line extension of the Stryker BioZip Suture Anchor System is substantially equivalent in material of construction, overall design, intended use, and safety and efficacy to the predicate device. The subject device was shown to have substantially equivalent performance when compared to the predicate device.
The line extension of the Stryker BioZip Suture Anchor System is considered substantially equivalent to the Stryker BioZip Suture Anchor System (#K023192).
Contact:
Date: May 7, 2004
Melissa Murphy Regulatory Representative Stryker Endoscopy 5900 Optical Court San Jose, CA 95138 (408) 754-2148
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 4 2004
Ms. Melissa Murphy Regulatory Representative Stryker Endoscopy 5900 Optical Court San Jose, California 95138
Re: K041305
Trade/Device Name: Stryker BioZip Suture Anchor System Regulation Number: 21 CFR 888.3040 Regulation Name: Fastener, fixation, biodegradable, soft tissue Regulatory Class: II Product Code: MAI Dated: May 7, 2004 Received: May 17, 2004
Dear Ms. Murphy:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosure) to regary to regars and the Medical Device Amendments, or to conninered prof to May 20, 1978, the eccordance with the provisions of the Federal Food, Drug, devices that have been roomstiled mequire approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The 1 ou may, merelors, mainer of the Act include requirements for annual registration, listing of general bonavil provision practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device to such additional controls. Existing major regulations affecting your device can may be subject to sach additions, Title 21, Parts 800 to 898. In addition, FDA may ou found in the Outsting your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I Teast of advised that I Dris and that your device complies with other requirements of the Act mal I DA has made a and regulations administered by other Federal agencies. You must of any I cacal statutes and regalations and limited to: registration and listing (21 Compry with an the Act 81 e FR Part 801); good manufacturing practice requirements as set CTN in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the clectronic forth in the quality by stems (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Ms. Melissa Murphy
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to oogin manteeing your antial equivalence of your device to a legally premarket nothlication. The PDA midning of backland of .
marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific advice for your as 110 110 110 - 4659. please note the regulation entitled, province Colliati the Office of Compulance an (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general information on your responsible in the toll-free number (800) 638-2041 or Manufacturers, International and Consulter Pressonal Provincial Stations of Smamain. html
Sincerely yours,
Miriam C. Provost
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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# Indications for Use
510(k) Number (if known): K041305
Device Name: Stryker BioZip Suture Anchor System
Indications For Use: The Styker BioZip Suture Anchor System is intended foruse in maloutions for tissue to bone in such procedures as:
| Shoulder: | Elbow, Wrist, Hand: |
|---------------------------------------------|-------------------------------------------------|
| Rotator cuff repair | Scapholunate ligament reconstruction |
| Bankart repair | Ulnar collateral ligament reconstruction radial |
| SLAP lesion repair | Collateral ligament reconstruction |
| Acromio-clavicular sepaeration repair | Biceps tendon reattachment |
| Capsular shift/capsulolabral reconstruction | |
| Biceps tenodesis | Foot & Ankle |
| Deltoid repair | Medial instability repair/reconstruction |
| | Lateral instability repair/reconstruction |
| Knee: | Achilles tendon repair/reconstruction |
| Extra capsular repairs | Midfoot reconstruction |
| Medial collateral ligament | Hallux valgus reconstruction |
| Lateral collateral ligament | |
| Posterior oblique ligament | Pelvis: |
| | Bladder neck suspension procedures |
| Illiotibial band tenosis | |
| Patellar tendon repair | |
The Stryker BioZip Suture Anchor System is intended for single-use only.
ర్లు Prescription Use __ (Part 21 CFR 801 Subpart D)
,
AND/OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Muriam C. Provost
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
**510(k) Number** K041305
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