(262 days)
The PolyLock System is indicated for use in the treatment of bone fractures, arthrodesis, osteochondritis, and interfragmentary indications in the small bones of the hand, foot, and ankle, including the distal tibia, talus, and calcaneus. Including, fusions of the forefoot and midfoot, stabilization of 1st, 2nd, 3rd, 4th, and 5th tarsometatarsal fusions, intercuneiform, navicular-cuneiform, talo-navicular, calcaneo-cuboid, and medial column fusions, first metatarsal osteotomies for hallux valgus/rigidus correction, first metatarsal fracture fixation, arthrodesis of the first metatarsal cuneiform joint, and arthrodesis/fusion of the first metatarsophalangeal joint.
The PolyLock Plating System consists of various shapes and sizes of plates for the management of orthopedic osteotomies, reconstruction, and trauma of the foot, ankle, and hand. Features include a low profile, limited contact plate capable of dynamic/manual compression, with threaded screw holes accepting both poly-axial and locking screws. The system also consists of poly-axial and locking screws with diameters consisting of 2.0mm, 2.4mm, 2.7mm, 3.5mm and 4.0mm with lengths from 8mm to 60mm. System instrumentation includes: drill bits, countersinks, K-wires, olive wires, depth gauges, reamers, driver shafts, guides, plate benders, clamps, and driver handles to facilitate the placement of the screws. The implants are intended for single use only. Instruments designed for bone removal are intended for single use only, such as: drill bits, countersinks, reamers, K-wires, and olive wires.
This document is a 510(k) premarket notification for a medical device (PolyLock Plating System). It does not contain any information about an AI/ML-based medical device study, acceptance criteria, or performance data related to AI/ML.
Instead, it's about a metallic bone fixation appliance. The "Non-clinical Test Summary" and "Clinical Test Summary" explicitly state:
- "Engineering rational was performed to show substantial performance equivalence."
- "No clinical studies were performed."
Therefore, I cannot provide details on the requested points because the provided text does not describe an AI/ML study. It details the submission of a physical medical device.
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March 4, 2022
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Fusion Orthopedics Eli Jacobson Associate Director of Engineering 4135 S Powder Road Mesa, Arizona 85212
Re: K211843
Trade/Device Name: PolyLock Plating System 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: January 28, 2022 Received: January 31, 2022
Dear Eli Jacobson:
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
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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 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,
Shumaya Ali, M.P.H. 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K211843
Device Name
PolyLock Plating System
Indications for Use (Describe)
The PolyLock System is indicated for use in the treatment of bone fractures, arthrodesis, osteochondritis, and interfragmentary indications in the small bones of the hand, foot, and ankle, including the distal tibia, talus, and calcaneus. Including, fusions of the forefoot and midfoot, stabilization of 1st, 2nd, 3rd, 4th, and 5th tarsometatarsal fusions, intercuneiform, navicular-cuneiform, talo-navicular, calcaneo-cuboid, and medial column fusions, first metatarsal osteotomies for hallux valgus/rigidus correction, first metatarsal fracture fixation, arthrodesis of the first metatarsal cuneiform joint, and arthrodesis/fusion of the first metatarsophalangeal joint.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| ☒Prescription Use (Part 21 CFR 801 Subpart D) ☐Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|
| --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
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Page 1 of 2
510(k) Summary: PolyLock Plating System
In accordance with 21 CFR 807.92 of the Federal Code of Regulations
| Date Prepared | June 11th, 2021 |
|---|---|
| Submitted By | Fusion Orthopedics, LLC4135 S. Power Rd., Suite 110Mesa, AZ 85212800-403-6876 |
| Primary Contact | Eli Jacobson4135 S. Power Rd., Suite 110Mesa, AZ 85212800-403-6876 Telee-mail: eli@fusionorthopedics.com |
| Trade Name | PolyLock Plating System |
| Common Name | Plate, Fixation, Bone |
| Class | II |
| Product Code | HRS, HWC |
| Regulation | 21 CFR Section 888.3030 - Single/multiple component metallic bone fixationappliances and accessories. |
| Device Panel | Orthopedic |
| Predicate Devices | Fusion Orthopedics: PolyLock Plating System (K202959) [Primary Predicate]Paragon 28: Gorilla Plating System (K203511) |
| DeviceDescription | The PolyLock Plating System consists of various shapes and sizes of plates for themanagement of orthopedic osteotomies, reconstruction, and trauma of the foot, ankle, andhand. Features include a low profile, limited contact plate capable of dynamic/manualcompression, with threaded screw holes accepting both poly-axial and locking screws. Thesystem also consists of poly-axial and locking screws with diameters consisting of 2.0mm,2.4mm, 2.7mm, 3.5mm and 4.0mm with lengths from 8mm to 60mm. Systeminstrumentation includes: drill bits, countersinks, K-wires, olive wires, depth gauges,reamers, driver shafts, guides, plate benders, clamps, and driver handles to facilitate theplacement of the screws. The implants are intended for single use only. Instrumentsdesigned for bone removal are intended for single use only, such as: drill bits, countersinks,reamers, K-wires, and olive wires. |
| Indications forUse | The PolyLock System is indicated for use in the treatment of bone fractures, osteotomies,arthrodesis, osteochondritis, and interfragmentary indications in the small bones of thehand, foot, and ankle, including the distal tibia, fibula, talus, and calcaneus. Including,fusions of the forefoot and midfoot, stabilization of 1st, 2nd, 3rd, 4th, and 5thtarsometatarsal fusions, intercuneiform, navicular-cuneiform, talo-navicular, calcaneo-cuboid, and medial column fusions, first metatarsal osteotomies for hallux valgus/rigiduscorrection, first metatarsal fracture fixation, arthrodesis of the first metatarsal cuneiformjoint, and arthrodesis/fusion of the first metatarsophalangeal joint. |
| Materials | Ti-6Al-4V (ASTM F136)Stainless Steel (ASTM F899) |
| Comparison ofTechnologicalCharacteristics | The PolyLock Plating System and the predicate plating systems implants are manufacturedfrom titanium alloy (ASTM F136), are compatible with similar sized screws, have similarwidths, thickness, lengths and designs/shapes. |
| Non-clinical TestSummary | Validations were performed on the cleaning, packaging and sterilization of the implants andassociated surgical instruments. Engineering rational was performed to show substantialperformance equivalence. The results of the testing demonstrate that the device issubstantially equivalent to the predicate device identified above. |
| Clinical TestSummary | No clinical studies were performed |
| Conclusions:Non- clinical andClinical | Fusion Orthopedics LLC considers the PolyLock Plating System to be equivalent to thepredicate devices listed above. This conclusion is based upon the devices' similarities inprinciples of operation, technology, materials and indications for use. |
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Page 2 of 2
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
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.(b)
Classification. Class II.