LOQTEQ VA Foot Plates 2.5

{0}------------------------------------------------ June 19, 2019 Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. aap Implantate AG Annesha Lahiri Head of Regulatory Affairs Lorenzweg 5 Berlin, D-12099 De Re: K182785 Trade/Device Name: LOOTEO VA Foot Plates 2.5 Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: HRS, HWC Dated: April 18, 2019 Received: April 29, 2019 Dear Annesha Lahiri: 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 {1}------------------------------------------------ 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, Shumava Ali. MPH 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 {2}------------------------------------------------ ### Indications for Use 510(k) Number (if known) K182785 Device Name LOQTEQ VA Foot Plates 2.5 Indications for Use (Describe) LOQTEQ® VA Plantar Fusion Plate 2.5, TMT 1: · plantar stabilization of arthrodesis/fusions of the first metatarsal joint (Lapidus procedure) LOOTEO® VA L-Fusion Plate 2.5: - · LisFranc Arthrodesis and/or Stabilization - 2nd Tarsometatarsal (TMT) Fusions LOQTEQ® VA Straight Fusion Plate 2.5: - · LisFranc Arthrodesis and/or Stabilization - 3rd Tarsometatarsal (TMT) Fusions LOQTEQ® VA Osteotomy Plate 2.5: First metatarsal osteotomies for hallux valgus correction including: - · Opening base wedge osteotomy - Closing base wedge osteotomy - Proximal Chevron osteotomy LOQTEQ® VA MTP Fusion Plate 2.5: Arthrodesis of the first metatarsophalangeal joint (MTP) including: - Primary MTP Fusion due to hallux rigidus and/or hallux valgus #### LOQTEQ® VA MTP Revision Plate 2.5: Arthrodesis of the first metatarsophalangeal joint (MTP) including: - Revision MTP Fusion - · Revision of failed first MTP Arthroplasty implant LOQTEQ® VA Metatarsal Straight Plate 2.5/LOQTEQ® VA Metatarsal L-Plate 2.5/LOQTEO® VA Metatarsal T-Plate 2.5 - · Metatarsal or metacarpal fractures and osteotomies - · Phalanges fractures and osteotomies LOQTEQ® VA X-Plate 2.5: · fixation of factures, osteotomies, nonunions, replantations, and fusions of small bone fragments, including the foot LOQTEQ® VA Hook Plate 2.5: · internal bone fixation for bone fractures of the 5th metatarsal of the foot LOOTEO® VA Plantar Fusion Plate 3.5, TMT 1: · plantar stabilization of arthrodesis/fusions of the first metatarsal joint (Lapidus procedure) {3}------------------------------------------------ #### 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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.qov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ Image /page/4/Picture/2 description: The image shows a logo with the letters 'aap' in a bold, sans-serif font. The letters are a deep blue color. A small, teal-colored circle is positioned below the right side of the letter 'p', creating a visual accent. The background is plain white. ## VOL_007_510(k) Summary 510(k) Summary LOQTEQ® VA Foot Plates 2.5 #### Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared | Submitter: | aap Implantate AG | |----------------|----------------------------------------| | Address: | Lorenzweg 5<br>D-12099 Berlin, Germany | | Telephone: | +49-30-750-19 -193 | | Telefax: | +49-30-750-19 -111 | | Contact: | Dr. Annesha Lahiri | | Date Prepared: | 2018-09-28 | ### Name of Device and Name/Address of Sponsor | Trade Name: | aap LOQTEQ® VA Foot Plates 2.5 | |-----------------|--------------------------------| | Common Name: | LOQTEQ® VA Foot Plates 2.5 | | Classification: | Class II per 21 CFR 888.3030 | | Device: | Orthopedics | | Product Code: | HRS and HWC | ### Predicate Devices | 510(K) Number | Trade Name | Manufacturer | |---------------|------------------------------------------------------|----------------| | K150520 | DARCO® Locking Bone Plate System | Wright Medical | | K121651 | ORTHOLOC 3Di Midfoot/Flatfoot System | Wright Medical | | K120359 | ORTHOLOCTM 3Di Hallux System-Primary Predicate | Wright Medical | | K090692 | ORTHOLOC® 2.0/2.4 Plate & ORTHOLOC® 2.0/2.4<br>Screw | Wright Medical | {5}------------------------------------------------ Image /page/5/Picture/2 description: The image shows a logo with the letters 'aap' in a bold, sans-serif font. The letters are a deep blue color. A small, teal-colored circle is positioned below the right leg of the letter 'p', creating a visual element that stands out against the white background. | K071264 | Synthes (USA) 2.4/2.7mm Locking Foot Module | Synthes | |---------|---------------------------------------------|---------| | K150456 | Arthrex Plates, Screws, and Staples | Arthrex | Table 1: List of predicate devices ### Intended Use: The system LOQTEQ® VA Foot Plates 2.5 is intended for use in stabilization and fixation of fractures, revision procedures, joint fusion and reconstruction of bones of the feet. Implants are intended for single use on adult human bone. ### Indications of Use: #### LOQTEQ® VA Plantar Fusion Plate 2.5, TMT 1: - plantar stabilization of arthrodesis/fusions of the first metatarsal joint (Lapidus procedure) ● #### LOQTEQ® VA L-Fusion Plate 2.5: - LisFranc Arthrodesis and/or Stabilization . - 2nd Tarsometatarsal (TMT) Fusions ● #### LOQTEQ® VA Straight Fusion Plate 2.5: - LisFranc Arthrodesis and/or Stabilization . - . 3rd Tarsometatarsal (TMT) Fusions ### LOQTEQ® VA Osteotomy Plate 2.5: First metatarsal osteotomies for hallux valgus correction including: - . Opening base wedge osteotomy - Closing base wedge osteotomy - Proximal Chevron osteotomy #### LOQTEQ® VA MTP Fusion Plate 2.5: Arthrodesis of the first metatarsophalangeal joint (MTP) including: - Primary MTP Fusion due to hallux rigidus and/or hallux valgus #### LOQTEQ® VA MTP Revision Plate 2.5: Arthrodesis of the first metatarsophalangeal joint (MTP) including: - Revision MTP Fusion - Revision of failed first MTP Arthroplasty implant ### LOQTEQ® VA Metatarsal Straight Plate 2.5/LOQTEQ® VA Metatarsal L-Plate 2.5/ LOQTEQ® VA Metatarsal T-Plate 2.5 : {6}------------------------------------------------ Image /page/6/Picture/2 description: The image shows a logo with the letters 'aap' in a bold, sans-serif font. The letters are a deep blue color, and there is a small, teal-colored circle positioned below the vertical line of the letter 'p'. The background is plain white, which makes the logo stand out. The logo is simple and modern. - Metatarsal or metacarpal fractures and osteotomies - . Phalanges fractures and osteotomies #### LOQTEQ® VA X-Plate 2.5: - fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and ● small bone fragments, including the foot #### LOQTEQ® VA Hook Plate 2.5: - internal bone fixation for bone fractures of the 5th metatarsal of the foot ● #### LOQTEQ® VA Plantar Fusion Plate 3.5, TMT 1: - plantar stabilization of arthrodesis/fusions of the first metatarsal joint (Lapidus procedure) . ### Product Description The LOQTEQ® VA Foot Plates 2.5 includes invasive products for the implantation on bones of the foot. The implants consist of a titanium-aluminum-vanadium alloy (TiAl6V4) and have different kind of holes that can be used for fixation with polyaxial angular stable locking screws or standard cortical screws. The DC-hole can be used for dynamic compression with a lag screw. As the case may be, the plates can be placed with a K-wire to fix the plate temporarily before the screws are tightened. Table 1 shows the products that are included in the LOQTEQ® VA Foot Plates 2.5. | Product name | Article<br>number | Width<br>[mm] | Thickness<br>[mm] | Length<br>[mm] | Image | |-------------------------------------------------------------|----------------------------------------------|----------------|-------------------|-------------------|----------------------------------------------------| | LOQTEQ® VA Plantar Fusion Plate 2.5, TMT 1 | PF 2511-04-2 | 9.6 | 2 | 34.5 | Image: metal plate with holes | | LOQTEQ® VA Plantar Fusion Plate 3.5, TMT 1 | PF 3511-04-2 | 11 | 2 | 38 | Image: metal plate with holes | | LOQTEQ® VA L-Fusion Plate | PF 2513-05-2 | 7.5 | 1.7 | 37.2 | Image: metal plate with holes | | LOQTEQ® VA Straight Fusion Plate 2.5 | PF 2515-04-2 | 7.2 | 1.6 | 34.7 | Image: metal plate with holes | | Product name | Article<br>number | Width<br>[mm] | Thickness<br>[mm] | Length<br>[mm] | Image | | LOQTEQ® VA X-Plate 2.5 | PF 2544-0X-2 | 15.7 –<br>19.9 | 1.6 | 24.6 –<br>32.6 | Image: LOQTEQ® VA X-Plate 2.5 | | LOQTEQ® VA Metatarsal<br>Straight Plate 2.5 | I: PF 2540-<br>0X-2 | I: 6 | I, L, T: 1.6 | I: 27 –<br>51 | Image: LOQTEQ® VA Metatarsal Straight Plate 2.5 | | LOQTEQ® VA Metatarsal<br>L-Plate 2.5 | L: PF 2541-<br>0X-2<br>PF 2542-0X-2 | L: 11 | | L: 26 –<br>32 | Image: LOQTEQ® VA Metatarsal L-Plate 2.5 | | LOQTEQ® VA Metatarsal<br>T-Plate 2.5 | T: PF 2543-<br>0X-2 | T: 11.8 | | T: 30.5 –<br>42.5 | Image: LOQTEQ® VA Metatarsal T-Plate 2.5 | | LOQTEQ® VA Hook Plate<br>2.5 | PF 2545-06-2<br>PF 2545-07-2<br>PF 2545-08-2 | 7 | 1.7 | 43 | Image: LOQTEQ® VA Hook Plate 2.5 | | LOQTEQ® VA Osteotomy<br>Plate 2.5 | PF 253X-06-2 | 12 | 1.6 | 30 – 35 | Image: LOQTEQ® VA Osteotomy Plate 2.5 | | LOQTEQ® VA MTP<br>Fusion Plate 2.5 | PF 252X-06-2 | 15.2 | 1.8 | 42 – 47 | Image: LOQTEQ® VA MTP Fusion Plate 2.5 | | LOQTEQ® VA MTP<br>Revision Plate 2.5 | PF 252X-09-2 | 15.5 | 2.2 | 60 | Image: LOQTEQ® VA MTP Revision Plate 2.5 | | LOQTEQ® VA Cortical<br>Screw 2.5, self-tapping | SK 2530-XX-2 | n.a. | n.a. | 08 – 40 | Image: LOQTEQ® VA Cortical Screw 2.5, self-tapping | | Cortical Screw 2.5, self-<br>tapping | SK 2512-XX-2 | n.a. | n.a. | 08 – 40 | Image: Cortical Screw 2.5, self-tapping | | Product name | Article<br>number | Width<br>[mm] | Thickness<br>[mm] | Length<br>[mm] | Image | | LOQTEQ® Cortical Screw<br>3.5, small head, self-<br>tapping | SK 3526-XX-2 | n.a. | n.a. | 10 - 40 | Image: blue screw | | Cortical Screw 3.5, self-<br>tapping | SK 3514-XX-2 | n.a. | n.a. | 10 - 40 | Image: gold screw | {7}------------------------------------------------ Image /page/7/Picture/2 description: The image shows the logo for the Australian Associated Press (AAP). The logo consists of the letters 'aap' in a bold, sans-serif font. The letters are a dark blue color, and there is a small, teal-colored circle positioned to the right of the letter 'p'. The logo is simple and modern in design. {8}------------------------------------------------ Image /page/8/Picture/2 description: The image shows the logo for the Australian Associated Press (AAP). The logo consists of the letters "aap" in a sans-serif font. The letters are a dark blue color, and there is a small teal circle below the right side of the letter "p". The background of the image is white. Table 2: Description of system components #### LOQTEQ® VA MTP Fusion Plate 2.5 & LOQTEQ® VA MTP Revision Plate 2.5 The LOQTEQ® VA MTP fusion plates consist of a MTP Fusion and MTP Revision plate. The MTP Fusion plate is available in two different lengths, while the MTP Revision plate is available in one length. Both kinds of plates can be obtained in right or left directed variant. The plates have polyaxial locking screw holes. These holes can be used for LOQTEQ® VA Cortical screws 2.5 mm. As an alternative, the polyaxial round holes can also be used with conventional non-locking 2.5 mm cortical screws (small head). The shape of the osteosynthesis plates fits to the anatomical condition of the metatarsal phalanges joint of the first metatarsal bone. Additionally, all plates have a (Revision plate has two) DC hole for compression in conjunction with conventional non-locking 2.5 mm cortical screws (small head). The plates have also one K-wire hole for the temporary fixation and positioning during the surgery. #### LOQTEQ® VA Straight Fusion Plate 2.5 & LOQTEQ® VA L-Fusion Plate 2.5 These LOQTEQ® VA - fusion plates, consists of a straight and a L-form plate in one length. The L-plate is available in a left and in a right variant. The plates have polyaxial locking screw holes. These holes can be used for LOQTEQ® VA Cortical screws 2.5 mm. Alternatively, the polyaxial round holes can also be used with conventional non-locking 2.5 mm cortical screws (small head). Furthermore, all plates have a (Revision plate has two) DC hole for compression in conjunction with conventional non-locking 2.5 mm cortical screws (small head). The shape of the osteosynthesis plate fits to the anatomy of the second and third tarsometatarsal joint. #### LOQTEQ® VA Hook Plate 2.5 The LOQTEQ® VA Hook plate is available in three different lengths and it has polyaxial locking screw holes, which can be used for LOQTEQ® VA Cortical screws 2.5 mm. As an alternative, the polyaxial round holes can also be used with conventional non-locking 2.5 mm cortical screws (small head). In addition, the plate has a DC hole for compression in conjunction with conventional non-locking 2.5 mm cortical screws (small head). The shape of the osteosynthesis plate fits to the anatomy of the fifth metatarsal bone. #### LOQTEQ® VA Metatarsal Plates 2.5 {9}------------------------------------------------ Image /page/9/Picture/2 description: The image shows the logo for the American Academy of Pediatrics (AAP). The logo consists of the letters 'aap' in a bold, sans-serif font. The letters are a dark blue color, and there is a small, teal-colored circle positioned below the 'p'. The logo is simple and modern, and it is easily recognizable. The LOQTEQ® VA Metatarsal plates, consist of a straight L- form and T-form plate and are available in different lengths. The plates have polyaxial locking screw holes, which can be used for LOQTEQ® VA Cortical screws 2.5 mm. On the other hand, the polyaxial round holes can also be used with conventional non-locking 2.5 mm cortical screws (small head). Moreover, all plates have a (Straight plate has two) DC hole for compression in conjunction with conventional non-locking 2.5 mm cortical screws (small head). The shape of the osteosynthesis plates fits to the anatomy of the metatarsal of the fore and midfoot. ### LOQTEQ® VA Osteotomy Plate 2.5 The LOQTEQ® VA Osteotomy Plate 2.5 is available in two different lengths. The plate has polyaxial locking screw holes, which can be used for LOQTEQ® VA Cortical screws 2.5 mm. As an alternative, the polyaxial round holes can also be used with conventional non-locking 2.5 mm cortical screws (small head). Additionally, the plate has a DC hole for compression in conjunction with conventional non-locking 2.5 mm cortical screws (small head). The shape of the osteosynthesis plate fits to the anatomy of the first metatarsal bone. #### LOQTEQ® VA Plantar Fusion Plate 2.5 / LOQTEQ® VA Plantar Fusion Plate 3.5 The plantar LOQTEQ® VA Fusion Plate 2.5/3.5, TMT1 have two polyaxial locking screw holes which can be used for LOQTEQ® VA Cortical screws 2.5 mm or 3.5 mm, respectively, the polyaxial round holes can also be used with conventional non-locking 2.5 mm or 3.5 mm cortical screws (small head). Also, the plates have two oblong holes in conjunction with conventional nonlocking 2.5 mm or 3.5 mm cortical screws (small head). The shape of the osteosynthesis plate fits to the anatomy of the first tarsometatarsal joint. ### LOQTEQ® VA X-Plate 2.5 The LOQTEQ® VA X-Plate 2.5 is available in different sizes: small, medium and large. The plate has polyaxial locking screw holes, which can be used for LOQTEQ® VA Cortical screws 2.5 mm. Otherwise, the polyaxial round holes can also be used with conventional non-locking 2.5 mm cortical screws (small head). Due to its unique shape, the X-Plate can be used at different bones of the foot e.g. for fractures of the midfoot. Furthermore, all plates have two K-wire holes for temporary fixation of the plate during the surgery. #### Substantial Equivalence The LOQTEQ® VA Foot Plates 2.5 has comparable intended use and indications for use as the predicate devices. The device has - comparable technological characteristics, - identical indications for use, ● - identical functionality, - comparable materials {10}------------------------------------------------ Image /page/10/Picture/2 description: The image shows the logo for the American Academy of Pediatrics (AAP). The logo consists of the letters 'aap' in a bold, sans-serif font, with the letters colored in a dark blue. A small, teal-colored circle is positioned to the right of the letter 'p', creating a visually distinct element within the logo. - comparable dimensions of components - . comparable mechanical properties (ensured by benchmark tests showing substantial equivalence – provided in this submission) Thus, the device is substantially equivalent to its predicates #### Performance Testing Bench testing was conducted to determine the substantial equivalence to the predicates. In all instances, the LOQTEQ® VA Foot Plates 2.5 functioned as intended and had similar results as the predicate devices. #### Performance Testing for the Plates In order to evaluate the mechanical safety of the LOQTEQ® VA Foot Plates 2.5, Static and Dynamic 4point-bending tests of bone plates according to ASTM F 382-14 have been performed. Test results (static and dynamic) were compared to the well clinically proven and equivalent benchmark products. The result of the static 4 point bending test has been used as basis for the dynamic tests. Testing was performed by an independent, certified and accredited test laboratory (MDD 93/42/EEC, ISO 17025): Questmed GmbH. The non-clinical data demonstrated that the device performs comparably to the predicates device for the same intended use. #### Performance testing for the screws - Some screws that are a part of this submission have been already cleared in - 1. K153034 - 2. K123875 - 3. K113652 - 4. K141949 The current submission includes some additional screw lengths which have bene tested in accordance with ASTM F543-13 - - SK 2512-08-2: Cortical Screw 2.5, small head T8, self-tapping, Length 8mm ● - SK 2530-08-2: LOQTEQ® VA Cortical Screw 2.5, T8, Length 8mm ● - SK 2530-36-2: LOQTEQ® VA Cortical Screw 2.5, T8, Length 36mm - SK 2530-38-2: LOQTEQ® VA Cortical Screw 2.5, T8, Length 38mm - SK 2530-40-2: LOQTEQ® VA Cortical Screw 2.5, T8, Length 40mm ● - SK 3526-10-2: LOQTEQ® Cortical Screw 3.5, small head, self-tapping, Length 10 mm ● {11}------------------------------------------------ Image /page/11/Picture/2 description: The image shows a logo with the letters 'aap' in a bold, sans-serif font. The letters are a deep blue color. A teal-colored circle is positioned below the vertical line of the letter 'p', creating a visual element that draws the eye. The background is plain white. These screws were tested for Maximum Torque, Breaking Angle, Insertion Torque according to ASTM F543-13 and in all cases, the subject screws can be stated as safe and fit for use without raising any question on the safety and effectiveness of the device. #### Conclusion Based on the indications for use, technological characteristics, performance testing, and comparison to the predicates, the LOQTEQ® VA Foot Plates 2.5 has been shown to be substantially equivalent to the predicate devices identified in this submission and does not present any different issues of safety or effectiveness. The results from the bench testing demonstrate that the device performs as good or better than the predicate devices.