Properly used, in the presence of adequate immobilization, absorbable BioCuff CM screw/washer maintains proximity between soft tissue and bone to facilitate the soft tissue reattachment. BioCuff C™ loses its strength over 20 to 50 weeks while the lesion of the tendon is healing. This indication is completely identical with the previously cleared BioCuffM (K001378).

The BioCuff C™ is not intended for use in and is contraindicated for: 1) Insufficient quality or quantity of bone, 2) Foreign body sensitivity to the implant material. Where the material is suspected a test should be made prior to implantation to rule out sensitivity. 3) Patients with active sepsis or infection. 4) Conditions, which tend to limit the patient's ability or willingness to restrict activities or follow directions during the healing and rehabilitation period.

Device Description

BioCuff CTM is composed of poly-L/D-lactide copolymer. This raw material is completely identical with the previously cleared Bionx Implants Inc. BioCuff™ (K001378).

The device description of BioCuff C™ screw and washer combination is as follows:

Composed of poly-L/D-lactide copolymer
-Lengths 18, 28 and 36mm.
Diameter 6.0 mm
-Cannulation for 1.5mm K-wire

The only modifications that were made are:

Cannulated design for easier installation of the product
Increased outer diameter
Minor design changes in head of the screw and washer accordingly
Revision of instrument set according to needs of cannulation. This means cannulated screwdriver, cannulated drill, grasper, cannulated bone tap, sterilization tray and K-wire. Instrument set is substantially equivalent to previously cleared Bionx Implants Inc. BioCuff™ screw/washer (K001378) and Cannulated SmartScrew (K974876, K992947).
Introduction of new reference numbers
Introduction of new trade name, BioCuff CTM

AI/ML Overview

This 510(k) submission (K013057) for the Bionx Implants Inc. BioCuff CTM is for a bioabsorbable soft tissue fixation fastener. The submission establishes substantial equivalence to a predicate device, the Bionx Implants Inc. BioCuff™ (K001378).

The core of this submission is demonstrating that the BioCuff CTM is substantially equivalent to the predicate device, BioCuff™. This means the acceptance criteria are implicitly those of the predicate device, and the study proves the new device meets these criteria by showing it has the same or very similar performance and safety characteristics.

Here’s an breakdown based on your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a substantial equivalence claim based on minor modifications and identical materials to a predicate, explicit numerical acceptance criteria and a detailed performance study with reported values for the new device (BioCuff CTM) against those criteria are not provided in the document in the format you expect for a novel device. Instead, the "acceptance criteria" are implied to be the performance characteristics of the predicate device, which the new device is claimed to match.

Acceptance Criteria (Implied from Predicate)	Reported Device Performance (BioCuff CTM)
Material Composition: Poly-L/D-lactide copolymer	Identical: Composed of poly-L/D-lactide copolymer
Intended Use: Maintains proximity between soft tissue and bone to facilitate reattachment; loses strength over 20-50 weeks during healing.	Identical: "This indication is completely identical with the previously cleared BioCuff™ (K001378)."
Contraindications:	Identical: The document explicitly states, "Also, like the predicate devices, the BioCuff Cᵀᴹ is not intended for use in and is contraindicated for...". The list of contraindications is then provided and is assumed to be the same as the predicate.
Dimensions (Predicate - BioCuff™): (Not explicitly stated in the provided text for the predicate, but implied by the changes.)	Modified: Lengths 18, 28, and 36mm; Diameter 6.0 mm (These are the new device dimensions, which are noted to be an increase in outer diameter from the predicate. The FDA's clearance implies this modification does not raise new safety or effectiveness concerns.)
Design: Non-cannulated	Modified: Cannulated design for easier installation; minor design changes in the head of the screw and washer.
Instrument Set: Non-cannulated instruments	Modified: Revision of instrument set to cannulated (screwdriver, drill, grasper, bone tap, sterilization tray, K-wire). Stated to be substantially equivalent to predicate and other cleared cannulated screws.
Overall Safety & Effectiveness: No new issues raised by modifications.	Confirmed: "The minor technological differences between BioCuff CTM and the predicate device do not raise any new issues of safety or effectiveness." FDA clearance letter confirms substantial equivalence.

2. Sample Size Used for the Test Set and Data Provenance

The provided text does not describe an independent clinical or performance study with a test set of patients or devices where data was collected. This 510(k) relies on a declaration of substantial equivalence to a previously cleared device. Therefore, there is no mention of a "test set" and thus no sample size or data provenance in the context of a new performance study.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

No new test set was used, and thus no expert ground truth establishment for a new test set is mentioned.

4. Adjudication Method for the Test Set

Not applicable as no new test set and no expert review for a new test set were conducted.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC study was performed or mentioned. The device is a physical implant, not an AI or imaging diagnostic tool that would typically involve a MRMC study.

6. Standalone Performance Study (Algorithm Only)

Not applicable. This is a medical device (implant), not an algorithm or AI system.

7. Type of Ground Truth Used

The "ground truth" for this submission is effectively the established safety and effectiveness profile of the predicate device (BioCuff™ K001378). The new device's substantial equivalence is argued based on its identical material, intended use, and minor design changes that do not alter its fundamental function or safety profile.

8. Sample Size for the Training Set

Not applicable. There is no mention of a "training set" as this is not an AI/ML device.

9. How the Ground Truth for the Training Set Was Established

Not applicable.

Summary

{0}------------------------------------------------

K013057
10FD

510(k) Summary Bionx Implants Inc. BioCuff CTM

Submitter's Name, Address, Telephone Number, and Contact I'crson

Bionx Implants, Inc. 1777 Sentry Parkway West Gwynedd Hall, Suite 400 Blue Bell, PA 19422

Contacts:

Gerard S. Carlozzi President and Chief Executive Officer Phone: (215) 643-5000 (215) 653-0984 Facsimile:

Bionx Implants Ltd. Tuija Annala Director, Quality and Regulatory Affairs P.O.Box 3 FIN-33721 Tampere Finland Phone: 358-3-316 5679 Facsimile: 358-3-316 5629

Date prepared: August 30, 2001

Name of the device:

Trade or Proprietary Name: BioCuff CTM A. B. Common Name: Bioabsorbable soft tissue fixation fastencr C. Classification Name: Bioabsorbable soft tissue fixation fastener D. Device Product Code: MAJ

Predicate Device:

Bionx Implants Inc. BioCuff™ (K001378)

Intended Use:

{1}------------------------------------------------

K013057
20F2

Also, like the predicate devices, the BioCuff C™ is not intended for use in and is contraindicated for:

Surgical procedures other than those listed. 】.
Conditions that may compromise fixation with BioCuff CTM (osteopenic, 2. comminuted bone, etc.).
Conditions that may retard healing (poor blood supply, past or potential ਲ, infection, elc.).
Active infection. 4.
Conditions that may limit the patient's ability or willingness to restrict న్. activities or follow directions during the healing period.
Foreign body sensitivity to materials. 6.

Device Description:

BioCuff CTM is composed of poly-L/D-lactide copolymer. This raw material is completely identical with the previously cleared Bionx Implants Inc. BioCuff™ (K001378).

The device description of BioCuff C™ screw and washer combination is as follows:

Composed of poly-L/D-lactide copolymer -
-Lengths 18, 28 and 36mm.
Diameter 6.0 mm -
-Cannulation for 1.5mm K-wire

The only modifications that were made are:

Cannulated design for easier installation of the product u
Increased outer diameter -
Minor design changes in head of the screw and washer accordingly -
Revision of instrument set according to needs of cannulation. This means cannulated screwdriver, cannulated drill, grasper, cannulated bone tap, sterilization tray and K-wire. Instrument set is substantially equivalent to previously cleared Bionx Implants Inc. BioCuff™ screw/washer (K001378) and Cannulated SmartScrew (K974876, K992947).
Introduction of new reference numbers -
Introduction of new trade name, BioCuff CTM -

Substantial Equivalence:

The minor technological differences between BioCuff CTM and the predicate device do not raise any new issues of safety or effectiveness.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and features the department's name around the perimeter. In the center is a stylized emblem consisting of three curved shapes, resembling a bird or abstract design. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 2 2001

Mrs. Tuija Annala Director, Quality and Regulatory Affairs Bionx Implants Ltd. Hermiankatu 6-8 L Tampere Finland

Re: K013057

Trade Name: BioCuff CTM Regulation Number: 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: MAI, HWC Dated: September 6, 2001 Received: September 6, 2001

Dear Mrs. Tuija Annala:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaon 910(t) proxime is substantially equivalent (dor in indications felerenced above and nave determined by marketed predicate devices marketed in interstate for use stated in the encrosule) to regally manetical povice Amendments, or to commence prior to May 20, 1976, the encordance with the provisions of the Federal Food, Drug, devices that have been reciasined in asses approval of a premarket approval application (PMA). allo Cosmetic Act (71ct) that ao nov requestly of the general controls provisions of the Act. The I ou may, increrore, market the act include requirements for annual registration, listing of general controls provisions of ractice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (600 as voyols. Existing major regulations affecting your device can thay be subject to subli additions, Title 21, Parts 800 to 898. In addition, FDA may ou louica in the overnments concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I loast be advisou that I Dr brains that your device complies with other requirements of the Act that I Dri has made a aver mixalations administered by other Federal agencies. You must or any I carated and the Act's requirements, including, but not limited to: registration and listing (21 Comply with an the rece or of an entry (1) ; good manufacturing practice requirements as set CFR Part 6077; adoning (21 CFR Part 820); and if applicable, the electronic forth in the quality by sections (Sections 531-542 of the Act); 21 CFR 1000-1050.

{3}------------------------------------------------

Page 2 - Mrs. Tuija Annala

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark McMillan

Celia M. Witten, Ph.D., MD Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

INDICATIONS FOR USE

510(K) Number (if known): K013057

Device Name:

BioCuff Circ

Indications for Use:

Properly used, in the presence of adequate immobilization, absorbable BioCull CM screw/washer maintains proximily between soft tissue and bone to facilitate the soft tissue reattachment. The BioCuff C™ Ioses its strength over 20 to 50 weeks while the Icsion of the tendon is healing.

(Please do not write below this line - continue on another page is needed) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

(Per 21 CFR 801.109)

OR Over-The-Counter Use_

for Mark N Milkman

10(k) Number K013057

Regulation Number and Section

§ 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.