Who is the manufacturer of PolyLock Plating System?

Fusion Orthopedics filed the 510(k) submission for PolyLock Plating System (K211843).

What is the FDA product code for PolyLock Plating System?

HRS. It is classified under 21 CFR 888.3030 as a Class 2 device in the Orthopedic panel.

What is the regulatory pathway for PolyLock Plating System?

510(k) clearance (submission type: Traditional).

What are the predicate devices for PolyLock Plating System?

Fusion Orthopedics: PolyLock Plating System (K202959); Paragon 28: Gorilla Plating System (K203511).

Who can help prepare an FDA 510(k) submission like PolyLock Plating System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

PolyLock Plating System

K211843 · Fusion Orthopedics · HRS · Mar 4, 2022 · Orthopedic

Device Facts

Record ID	K211843
Device Name	PolyLock Plating System
Applicant	Fusion Orthopedics
Product Code	HRS · Orthopedic
Decision Date	Mar 4, 2022
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 888.3030
Device Class	Class 2
Attributes	Therapeutic

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, 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.

Device Story

PolyLock Plating System consists of metallic bone plates and screws for orthopedic reconstruction, trauma, and osteotomies. Plates feature low-profile, limited-contact design with threaded holes for poly-axial and locking screws (2.0mm–4.0mm diameters). System includes surgical instrumentation (drill bits, countersinks, K-wires, reamers, drivers, guides, benders, clamps). Used by surgeons in clinical/OR settings to stabilize bone segments; facilitates manual/dynamic compression. Implants and specific instruments (drill bits, countersinks, reamers, wires) are single-use. Provides mechanical fixation to support bone healing and fusion.

Clinical Evidence

No clinical studies were performed. Substantial equivalence is supported by engineering rationales and bench testing regarding cleaning, packaging, and sterilization validation.

Technological Characteristics

Materials: Ti-6Al-4V (ASTM F136) and Stainless Steel (ASTM F899). System includes metallic plates and screws of various sizes. Mechanical fixation via poly-axial and locking screws. Single-use implants and specific instruments. No software or electronic components.

Indications for Use

Indicated for patients requiring bone fracture treatment, arthrodesis, osteochondritis, or interfragmentary fixation in small bones of the hand, foot, and ankle (e.g., distal tibia, talus, calcaneus, forefoot/midfoot fusions, hallux valgus/rigidus correction).

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.

Predicate Devices

Fusion Orthopedics: PolyLock Plating System (K202959)
Paragon 28: Gorilla Plating System (K203511)

Related Devices

K202959 — PolyLock Plating System · Fusion Orthopedics, LLC · Nov 24, 2020
K192323 — PolyLock Small Bone Plating System · Fusion Orthopedics, LLC · Nov 18, 2019
K130964 — GRIDLOCK PLATING SYSTEM · Trilliant Surgical, Ltd. · May 8, 2013
K163361 — ANTHEM Fracture System · Globus Medical, Inc. · Apr 7, 2017
K181820 — Medline Unite Mini Plates and Screws · Medline Industries, Inc. · Nov 1, 2018

Submission Summary (Full Text)

{0}------------------------------------------------ March 4, 2022 Image /page/0/Picture/1 description: The image contains 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. 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 {1}------------------------------------------------ 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 {2}------------------------------------------------ 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) | |-------------------------------------------------| |-------------------------------------------------| | <div> ☒Prescription Use (Part 21 CFR 801 Subpart D) ☐Over-The-Counter Use (21 CFR 801 Subpart C) </div> | |---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| |---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| 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.gov* *"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."* FORM FDA 3881 (7/17) Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. {3}------------------------------------------------ ## 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, 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 Plating System | | Common Name | Plate, Fixation, Bone | | Class | II | | Product Code | HRS, HWC | | Regulation | 21 CFR Section 888.3030 - Single/multiple component metallic bone fixation appliances and accessories. | | Device Panel | Orthopedic | | Predicate Devices | Fusion Orthopedics: PolyLock Plating System (K202959) [Primary Predicate] Paragon 28: Gorilla Plating System (K203511) | | Device Description | 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. | | 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, 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 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 | Ti-6Al-4V (ASTM F136) Stainless Steel (ASTM F899) | | Comparison of Technological Characteristics | The PolyLock Plating System and the predicate plating systems implants are manufactured from titanium alloy (ASTM F136), 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 substantial 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. | {4}------------------------------------------------ K211843 Page 2 of 2