K Number
K202959
Device Name
PolyLock Plating System
Date Cleared
2020-11-24

(55 days)

Product Code
Regulation Number
888.3030
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended 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, 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.
Device Description
The PolyLock Plating 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, 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.
More Information

Not Found

No
The device description and summary of performance studies describe a mechanical plating system and associated instruments, with no mention of software, algorithms, or AI/ML capabilities.

Yes
The device is indicated for use in the treatment of various bone conditions, including fractures, arthrodesis, and osteochondritis, which are medical conditions, thereby classifying it as a therapeutic device.

No

The PolyLock System is described as a plating system intended for the treatment of bone fractures and fusions, consisting of plates, screws, and surgical instruments. Its function is to provide stabilization and fixation, which are therapeutic actions, not diagnostic.

No

The device description explicitly details physical components such as plates, screws, and surgical instruments, indicating it is a hardware-based medical device.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use clearly describes the device as being used for the surgical treatment of bone fractures, arthrodesis, and other orthopedic conditions in the small bones of the hand and foot. This is a therapeutic use, not a diagnostic one.
  • Device Description: The device description details plates, screws, and surgical instruments used for bone fixation and manipulation. These are all components of a surgical implant system, not a diagnostic test.
  • Lack of Diagnostic Elements: There is no mention of the device being used to analyze samples (like blood, urine, or tissue) or to provide information about a patient's health status through in vitro testing.

IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a surgical implant and instrument system used directly on the patient's body for treatment.

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, 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.

Product codes (comma separated list FDA assigned to the subject device)

HRS, HWC

Device Description

The PolyLock Plating 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, 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.

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, midfoot, 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 (study type, sample size, AUC, MRMC, standalone performance, key results)

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 (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

Fusion Orthopedics: PolyLock Small Bone Plating System (K192323), Medline UNITE: Foot Recon Plating System (K151235), Wright Medical ORTHOLOC 3Di Reconstruction System: CROSSCHECK Module (K152974), Stryker: Anchorage Plating System (K172148)

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

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

November 24, 2020

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. Food & Drug Administration".

Fusion Orthopedics, LLC Eli Jacobson Official Correspondent 4135 S. Power Rd., Suite 110 Mesa, Arizona 85212

Re: K202959

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: September 30, 2020 Received: September 30, 2020

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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

1

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 (OS) 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 mediation-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: 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)

K202959

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 and foot. Including, fusions of the forefoot and midfoot, stabilization of 1st, 2nd, 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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510(k) Summary: PolyLock Plating System

In accordance with 21 CFR 807.92 of the Federal Code of Regulations

Date PreparedSeptember 30th, 2020
Submitted ByFusion Orthopedics, LLC
4135 S. Power Rd., Suite 110
Mesa, AZ 85212
800-403-6876
Primary ContactEli Jacobson
4135 S. Power Rd., Suite 110
Mesa, AZ 85212
800-403-6876 Tele
e-mail: eli@fusionorthopedics.com
Trade NamePolyLock Plating System
Common NamePlate, Fixation, Bone
Classll
Product CodeHRS, HWC
Regulation21 CFR Section 888.3030 - Single/multiple component metallic bone fixation
appliances and accessories.
Device PanelOrthopedic
Predicate DevicesFusion Orthopedics: PolyLock Small Bone Plating System (K192323) [Primary Predicate]
Medline UNITE: Foot Recon Plating System (K151235)
Wright Medical ORTHOLOC 3Di Reconstruction System: CROSSCHECK Module (K152974)
Stryker: Anchorage Plating System (K172148)
Device
DescriptionThe PolyLock Plating 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,
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.
Indications for
UseThe 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 valqus/rigidus
correction, first metatarsal fracture fixation, arthrodesis of the first metatarsal cuneiform
joint, and arthrodesis/fusion of the first metatarsophalangeal joint.
MaterialsStainless steel (ASTM F899)
Ti-6AI-4V (ASTM F136)

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| Comparison of
Technological
Characteristics | The PolyLock Plating System and the predicate plating systems are manufactured from
titanium, are compatible with similar sized screws, have similar widths, thickness, lengths
and designs/shapes. |
|---------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 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. |