(83 days)
No
The 510(k) summary describes a system of plates, screws, and instruments for orthopedic surgery and does not mention any AI or ML components or functionalities.
Yes
The device is indicated for use in the treatment of bone fractures, osteotomies, arthrodesis, osteochondritis, and interfragmentary indications, which are therapeutic applications.
No
This device, the PolyLock System, is designed for the treatment of bone fractures, osteotomies, and fusions by providing plates and screws for stabilization. It is a surgical implant system, not a device used to diagnose medical conditions.
No
The device description explicitly details various shapes and sizes of plates, screws, and a comprehensive set of surgical instruments (drill bits, countersinks, K-wires, etc.). These are all physical hardware components, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- PolyLock System Function: The PolyLock System is a surgical implant and instrumentation used to physically stabilize and fix bone fractures, osteotomies, and fusions in the hand and foot. It is used in vivo (within the living body) during a surgical procedure.
- Lack of Diagnostic Activity: The description clearly outlines its use in surgical repair and reconstruction, not in analyzing biological samples for diagnostic purposes.
The information provided about the device's intended use, description, anatomical site, and performance studies all point to it being a surgical orthopedic device, not an IVD.
N/A
Intended Use / Indications for Use
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 and foot. Including, fusions of the forefoot and midfoot. stabilization of 1st, 2nd, 3rd, 4th, and 5th tarsometatarsal fusions, intercuneiform, 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.
Product codes
HRS, HWC
Device Description
The PolyLock System consists of various shapes and sizes of plates for the management of small bone orthopedic osteotomies, reconstruction, and trauma. 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 and 2.7mm and lengths from 8mm to 26mm. 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
small bones of the hand and foot, forefoot and midfoot, 1st, 2nd, 3rd, 4th, and 5th tarsometatarsal, intercuneiform, navicular-cuneiform, talo-navicular, calcaneo-cuboid, medial column, first metatarsal, first metatarsophalangeal joint
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Non-clinical Test Summary: Validations were performed on the cleaning, packaging and sterilization of the implants and associated surgical instruments. Engineering rational was performed to show performance equivalence. The results of the testing demonstrate that the device is substantially equivalent to the predicate device identified above.
Clinical Test Summary: No clinical studies were performed
Key Metrics
Not Found
Predicate Device(s)
K072740, K181820, K151235, K163039, K113048, K100776, K071264
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image contains two logos. The first logo on the left is the Department of Health & Human Services logo. The second logo on the right is the FDA logo, which stands for U.S. Food & Drug Administration. The FDA logo is in blue.
November 18, 2019
Fusion Orthopedics, LLC Eli Jacobson Official Correspondent 4135 S. Power Rd. Suite 110 Mesa, Arizona 85212
Re: K192323
Trade/Device Name: PolyLock Small Bone 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: August 9, 2019 Received: August 27, 2019
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.
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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 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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Indications for Use
510(k) Number (if known)
K192323
Device Name PolyLock Small Bone 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 and foot. Including, fusions of the forefoot and midfoot. stabilization of 1st, 2nd, 3rd, 4th, and 5th tarsometatarsal fusions, intercuneiform, 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) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary: PolyLock Small Bone Plating System
| Date Prepared | August 9th, 2019 |
|---|---|
| Submitted By | Fusion Orthopedics, LLC |
| 4135 S. Power Rd., Suite 110 | |
| Mesa, AZ 85212 | |
| 800-403-6876 | |
| Primary Contact | Eli Jacobson |
| 4135 S. Power Rd., Suite 110 | |
| Mesa, AZ 85212 | |
| 800-403-6876 Tele | |
| e-mail: eli@fusionorthopedics.com | |
| Trade Name | PolyLock Small Bone Plating System |
| Common Name | Plate, Fixation, Bone |
| Class | II |
| Product Code | HRS, HWC |
| Regulation | 21 CFR 888.3030 - Single/multiple component metallic bone fixation appliances and accessories |
| Device Panel | Orthopedic |
| Predicate Devices | M2 Modular Foot-Osteosynthesis System (K072740) [Primary Predicate] |
| Medline UNITE: Mini Foot Plating System (K181820) | |
| Medline UNITE: Foot Recon Plating System (K151235) | |
| Wright Medical ORTHOLOC 3Di Small Bone Plating System (K163039) | |
| Wright Medical MaxLock Extreme (K113048) | |
| DePuy Synthes LCP ForeFoot/MidFoot (K100776) | |
| DePuy Synthes Locking Foot Module (K071264) | |
| Reference | |
| Device | FuzeFix Screw System, Fusion Orthopedics (K170038) |
| Device | |
| Description | The PolyLock System consists of various shapes and sizes of plates for the management of |
| small bone orthopedic osteotomies, reconstruction, and trauma. 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 and 2.7mm and lengths | |
| from 8mm to 26mm. 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. | |
| Indications for | |
| Use | The PolyLock System is indicated for use in the treatment of bone fractures, osteotomies, |
| arthrodesis, osteochondritis, and interfragmentary indications in the small bones of the hand | |
| and foot. 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. | |
| Materials | Stainless steel (ASTM F899) |
| Ti-6AI-4V (ASTM F136) | |
| Substantial | |
| Equivalence | |
| Claimed to | |
| Predicate Devices | The PolyLock Small Bone Plating System is substantially equivalent to the predicate |
| devices in terms of intended use, design, materials used, mechanical safety, and | |
| performances. | |
| Non-clinical Test | |
| Summary | Validations were performed on the cleaning, packaging and sterilization of the implants and |
| associated surgical instruments. Engineering rational was performed to show performance | |
| equivalence. The results of the testing demonstrate that the device is substantially | |
| equivalent to the predicate device identified above. | |
| Clinical Test | |
| Summary | No clinical studies were performed |
| Conclusions: | |
| Non- clinical and | |
| Clinical | Fusion Orthopedics LLC considers the PolyLock Small Bone Plating System to be |
| equivalent to the predicate devices listed above. This conclusion is based upon the devices' | |
| similarities in principles of operation, technology, materials and indications for use. |
In accordance with 21 CFR 807.92 of the Federal Code of Regulations
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