RESORBABLE INTERFERENCE SCREW by ARTHROTEK, INC.

Indications for the Resorbable Interference Screw includes use in soft tissue reattachment procedures in the shoulder, wrist/hand, ankle/foot, elbow, and knee. Specific indications include the following:

Shoulder: Batkart repair, SLAP lesion repair, acromio-clavioular separation, rotator cuff repair, capsule repair or capsulolabral reconstruction, biceps tenodesis, deltoid repair. Wrist/Hand: Scapholunate ligament reconstruction, ulnat/radial collateral ligament

reconstruction.

Ankle/Foot: Lateral stabilization, medial stabilization, Achilles tendon repair/reconstruction, hallux valgus reconstruction, mid- and forefoot reconstruction.

Elbow: Tennis elbow repair, ultar or radial collateral ligament reconstruction, biceps tendon reconstruction.

Knee: Extra-capsular repair, medial collateral ligament (MCL) repair, lateral collateral ligament (LCL) repair, posterior oblique ligament repair, joint capsule closure, iliotibial band tenodesis reconstruction, patellar ligament/tendon repair, and vastus medialis obliquus (VMO) muscle advancement.

In addition to the above indications, the 7.0, 8.0, 9.0, 10.0, 11.0, and 12.0mm screws are indicated for the following uses:

1. To provide interference fixation of patellar bone-tendon-bone grafts in anterior cruciate ligament (ACL) reconstruction.
1. To provide interference fixation during femoral and/or tibial fixation in anterior cruciate ligament reconstruction using a soft tissue graft (semitendinosus, gracilis).
1. To provide interference fixation during posterior cruciate ligament (PCL) reconstruction.

Device Description

The 3 mm, 4 mm, 6 mm, 10 mm, 11 mm, and 12 mm as well as the 9 mm x 35 mm Resorbable Interference Screws are an addition to the 7 mm, 8 mm, and 9 mm interference screws already cleared in 510(K) K982497. They are made of the same LactoSorb® material as the predicate devices.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, the "Resorbable Interference Screw." This type of submission focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving a device meets specific acceptance criteria through extensive studies.

Therefore, the input document does not contain the information requested for acceptance criteria and a study proving the device meets those criteria, as typically understood for new device performance claims.

Here's a breakdown of why and what information is present related to equivalency:

Why the requested information is not available in the document:

Acceptance Criteria and Device Performance: The document does not define specific performance metrics (e.g., tensile strength, degradation rate, biocompatibility standards with defined thresholds) that the "Resorbable Interference Screw" had to meet. Instead, it relies on demonstrating that the new screw is substantially equivalent to existing, legally marketed screws.
Study Proving Acceptance Criteria: Because specific acceptance criteria with defined thresholds are not provided, there's no study described that "proves" the device meets them in the conventional sense. The "study" mentioned is "Non-Clinical Testing" for substantial equivalence.

Information available related to equivalency:

A table of acceptance criteria and the reported device performance:
- Acceptance Criteria (Implicit for Substantial Equivalence): The implicit acceptance criterion is that the "Resorbable Interference Screw" must be substantially equivalent to the predicate devices.
  - Predicate Devices:
    - Arthrotek Interference Screw - Arthrotek Inc. (K982497)
    - Soft Tissue Screw and Washer - Arthrotek Inc. (K012572)
    - Resorbable Screw Anchor - Arthrotek Inc. (K012872)
- Reported Device Performance (as demonstrated for substantial equivalence):
  - Non-Clinical Testing: "Mechanical testing was done on the 3.0 mm Resorbable Interference Screw. This testing indicated that the Resorbable Interference Screw was substantially equivalent to the predicate devices."
  - Materials & Manufacturing: "The Resorbable Interference Screw is made of the same materials, using the same manufacturing processes, and conforming to the same standards as the predicated Arthrotek Interference Screw (K982497)."
  - Intended Use & Indications: The new device shares the same intended use (soft tissue fixation to bone) and expanded indications (specific shoulder, wrist/hand, ankle/foot, elbow, and knee procedures, including ACL/PCL reconstruction) as the predicate devices and prior cleared versions.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- The document states "Mechanical testing was done on the 3.0 mm Resorbable Interference Screw." It does not specify the sample size for this mechanical testing.
- Data provenance (country, retrospective/prospective) is not mentioned.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This was mechanical testing, not a study requiring expert readers or ground truth established by clinical experts.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No adjudication method is mentioned as it was mechanical testing.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This is not an AI or imaging device. No MRMC study was performed.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the mechanical testing, the "ground truth" would be the established engineering and materials standards (implied by "conforming to the same standards as the predicated Arthrotek Interference Screw") and the performance characteristics of the predicate devices.
The sample size for the training set:
- Not applicable. There is no mention of a "training set" as this is not a machine learning device.
How the ground truth for the training set was established:
- Not applicable. There is no mention of a "training set."

Conclusion:

The document focuses on demonstrating substantial equivalence to existing devices through similar materials, manufacturing, intended use, and general performance (indicated by mechanical testing outcome). It explicitly states, "Clinical testing: Clinical testing was not required for these components to support substantial equivalence." This means the device was not subjected to a study designed to meet specific new acceptance criteria in the way a novel, high-risk device or an AI device might be.

Summary

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JUL 2 8 2004

K 041274
pg 1 of 2

510(k) Summary

Arthrotek. Inc. Applicant or Sponsor: (A wholly owned subsidiary of Biomet, Inc.) 56 East Bell Drive P.O. Box 587 Warsaw, Indiana 46581-0587

Contact Person:	Gary BakerBiomet Manufacturing Corp.P.O. Box 587Warsaw, Indiana 46581-0587Phone: (574) 267-6639FAX: (574) 372-1683
Proprietary Name:	Resorbable Interference Screw
Common or Usual Name:	Interference Screw

Classification Name: Screw, Fixation, Bone (21 CFR §888.3040)

Legally Marketed Devices To Which Substantial Equivalence Is Claimed:

Arthrotek Interference Screw - Arthrotek Inc. (K982497) Soft Tissue Screw and Washer - Arthrotek Inc. (K012572) Resorbable Sorew Anchor - Arthrotek Inc. (K012872)

Device Description: The 3 mm, 4 mm, 6 mm, 10 mm, 11 mm, and 12 mm as well as the 9 mm x 35 mm Resorbable Interference Screws are an addition to the 7 mm, 8 mm, and 9 mm interference screws already cleared in 510(K) K982497. They are made of the same LactoSorb® material as the predicate devices.

Intended Use: The Resorbable Interference Screw is intended for soft tissue fixation to bone.

ਉਤੇ

MAILING ADDRESS P.O. Box 587 Warsaw, IN 46581-0587

1999

SHIPPING ADDRESS 56 E. Bell Drive Warsaw, IN 46582

FAX 574.267.8137

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Page 2 of 2

Indications For Use: Indications for the Resorbable Interference Screw includes use in soft tissue reattachment procedures in the shoulder, wrist/hand, ankle/foot, elbow, and knee. Specific indications include the following:

reconstruction.

Ankle/Foot: Lateral stabilization, medial stabilization, Achilles tendon repair/reconstruction, hallux valgus reconstruction, mid- and forefoot reconstruction.

Elbow: Tennis elbow repair, ultar or radial collateral ligament reconstruction, biceps tendon reconstruction.

In addition to the above indications, the 7.0, 8.0, 9.0, 10.0, 11.0, and 12.0mm screws are indicated for the following uses:

1. To provide interference fixation of patellar bone-tendon-bone grafts in anterior cruciate ligament (ACL) reconstruction.
1. To provide interference fixation during femoral and/or tibial fixation in anterior cruciate ligament reconstruction using a soft tissue graft (semitendinosus, gracilis).
1. To provide interference fixation during posterior cruciate ligament (PCL) reconstruction.

Summary of Technologies: The Resorbable Interference Screw is made of the same materials, using the same manufacturing processes, and conforming to the same standards as the predicated Arthrotek Interference Screw (K982497). More sizes have been added.

Non-Clinical Testing: Mechanical testing was done on the 3.0 mm Resorbable Interference Screw. This testing indicated that the Resorbable Interference Screw was substantially equivalent to the predicate devices

Clinical Testing: Clinical testing was not required for these components to support substantial equivalence

All trademarks are property of Blomel, Inc.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or bird in flight. The symbol is composed of three curved lines that suggest movement and dynamism.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 8 2004

Arthrotek, Inc. C/o Mr. Gary Baker Biomet Manufacturing Corporation P.O. Box 587 Warsaw, Indiana 46581-0587

Re: K041274

Trade/Device Name: Resorbable Interference Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: May 11, 2004 Received: May 12, 2004

Dear Mr. Baker:

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. 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Gary Baker

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), 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) you may obtain. 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 A. Milken

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation

Center for Devices and Radiological Health

Enclosure

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K041274

Indications for Use

510(k) Number: K041274

Device Name: Resorbable Interference Screw

Indications For Use: Indications for the Resorbable Interference Screw includes use in soft tissue indications For OSC. Indications for the Resorbeative and knee. Specific indications include the following:

Shoulder: Bankart repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule repair or capsulolabral reconstruction, biceps tenodesis, deltoid repair. Capsure repair of odposition in reconstruction, ulnat/radial collateral ligament reconstruction.

Ankle/Foot: Lateral stabilization, medial stabilization, Achilles tendon repair/reconstruction, hallux valgus reconstruction, mid- and forefoot reconstruction.

nanux valgus reconstruction, mar and collateral ligament reconstruction, biceps tendon reconstruction.

reconstruction.
Knee: Extra-capsular repair, media) collateral ligament (MCL) repair, lateral collected to desig (LCL) repair, posterior oblique ligament repair, joint capsule closure, iliotibial band tenodesis (CCC) repair, posterior oonque igazion repair, and vastus medialis obliquus (VMO) muscle advancement.

In addition to the above indications, the 7.0, 8.0, 9.0, 10.0, 11.0, and 12.0 mm screws are indicated for the following uses:

1. To provide interference fixation of patellar bone-tendon-bone grafts in anterior cruciate ligament (ACL) reconstruction.
To provide interference fixation during femoral and/or tibial fixation in anterior 2. To provide interestion using a soft tissue graft (semitendinosus, gracilis).
To provide interference fixation during posterior cruciate ligament (PCL) 3. reconstruction.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use
(21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Minh
(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

510(k) Number K041274
3

Page 1 of 1

Regulation Number and Section

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.