2.8 & 3.5MM LACTOSCREW SUTURE ANCHORS by ARTHROTEK, INC.

Indications for the 2.8 and 3.5mm LactoScrew® Suture Anchors include use in soft tissue reattachment procedures in the shoulder, wrist/hand, ankle/foot, elbow and knee. Specific indications are as follows: Shoulder: Bankart repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule repair or capsulolabral reconstruction, biceps tendodesis, deltoid repair. Wrist/Hand: Scapholunate ligament reconstruction, ulnar/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, ulnar or radial collateral ligament reconstruction, biceps tendon reconstruction. Knee: Medial collateral ligament repair, lateral ligament repair, posterior oblique ligament repair, joint capsule closure, iliotibial band tendodesis, and patellar ligament/tendon repair.

Device Description

The 2.8 and 3.5mm LactoScrew® Suture Anchors, which are comprised of LactoSorb® resorbable copolymer (85% PLLA/15% PGA), are molded suture anchors used to reattach soft tissue to bone. All 2.8 and 3.5mm LactoScrew® Suture Anchors are pre-loaded with either one or two sutures.

AI/ML Overview

The provided text is a 510(k) summary for the 2.8 and 3.5mm LactoScrew® Suture Anchors. This documentation is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving that the device meets specific acceptance criteria through a clinical study.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth for this specific device is not present in the provided document. The document explicitly states:

"Clinical Testing: None provided as a basis for substantial equivalence."

It instead relies on "Non-Clinical Testing" which "indicated that the devices were functional within their intended use" and a comparison of technological characteristics to predicate devices.

Summary of available information based on the prompt's request:

1. A table of acceptance criteria and the reported device performance

Not provided. The document does not specify quantitative acceptance criteria or performance metrics derived from clinical testing for this device. It only states that "Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the devices were functional within their intended use."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. No clinical test set or data provenance is mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. No clinical test set requiring expert ground truth is mentioned.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No clinical test set requiring adjudication is mentioned.

5. 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 device is a physical medical device (suture anchor), not an AI-powered diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. No clinical ground truth is mentioned. The basis for substantial equivalence was "Non-Clinical Testing" for functionality and comparison to predicate devices.

8. The sample size for the training set

Not applicable. No training set data is mentioned for this type of device submission.

9. How the ground truth for the training set was established

Not applicable. No training set data or ground truth establishment process is mentioned.

Summary

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K 06180/

510(k) Summary

Preparation Date: June 23, 2006 Arthrotek, Inc. Applicant/Sponsor: Susan Alexander Contact Person: 2.8 and 3.5mm LactoScrew@ Suture Anchors Proprietary Name: Common Name; Resorbable suture anchor Classification Name: Fastener, Fixation, Biodegradable, Soft Tissue (21 CFR §888.3030)

Legally Marketed Devices To Which Substantial Equivalence Is Claimed:

Resorbable Interference Screw	K041274 Biomet, Inc.
Laut-O-Gen Analysis	VA03272 Biomet, Inc.

K003273 . LactoSorb® Screw Anchors
Device Description: The 2.8 and 3.5mm LactoScrew® Suture Anchors, which are comprised of LactoSorb® resorbable copolymer (85% PLLA/15% PGA), are molded suture anchors used to reattach soft tissue to bone. All 2.8 and 3.5mm LactoScrew® Suture Anchors are pre-loaded with either one or two sutures.

Intended Use: Indications for the 2.8 and 3.5 mm I.actoScrew® Suture Anchors include use in soft tissue reattachment procedures in the shoulder, wrist/hand, ankle/foot, elbow and knee. Specific indications are as follows:

Shoulder: Bankart repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule repair or capsulolabral recon:truction, biceps tendodesis, deltoid repair. Wrist/Hand: Scapholunate ligament reconstruction, ulnar/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, ulnar or radial collateral ligament reconstruction, biceps tendon reconstruction.

Knee: Medial collateral ligament repair, lateral ligament repair, posterior oblique ligament repair, joint capsule closure, iliotibial band tendodesis, and patellar ligament/tendon repair.

Summary of Technologies: The technological characteristics (material, design, sizing, indications) of the 2.8 and 3.5mm LactoScrew® Suture Anchors are similar or identical to the predicate devices.

Non-Clinical Testing; Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the devices were functional within their intended use.

Clinical Testing: None provided as a basis for substantial equivalence.

All trademarks are property of Biomet, Inc. unless otherwisis noted.

MAHANG ADDRESS Pr). Box 587 Warsaw, IN 465H1 0587

1999

SHIPPING ADDRESS 56 E. Bell Drive Wars:nv. IN 46583

OFFICE 574.207.66.39

FAX 574.267.8147

5-1

IC MAII bioman (colsic Bicarner com

AUG - 7 2006

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features a stylized depiction of a human figure, represented by four curved lines, symbolizing health and well-being. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the figure.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

ufacturing Corp

% Biomet Manufacturing Corp. Ms. Susan Alexander Regulatory Specialist P.O. Box 587 Warsaw, Indiana 46581-0587

Re: K061801

Athrotek, Inc.

Trade/Device Name: 2.8 and 3.5mm LactoScrew® Suture Anchors Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: JDR, HWC Dated: June 23, 2006 Received: June 26, 2006

AUG - 7 2006

Dear Ms. Alexander:

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

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Page 2 -- Ms. Susan Alexander

forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 vou desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.

Sincerely yours,

Sincercly yours,

Hubert Lemmer
C. Mark N. Mcllwraith

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indication® for Use

510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Device Name: 2.8 & 3.5mm LactoScrew® Suture Anchors

Indications For Use:

ons are us Tollows repair, capsule repair or capsulolabral reconstruction, biceps tendodesis, deltoid repair. Wrist/Hand: Scapholunate ligament reconstruction, ulnar/radial collateral ligament reconstruction.

Ankle/Foot: Lateral stabilization, medial stabilization, Achilles tendon Ankler out Each Beatler Station, mid- and forefoot reconstruction, mid- and forefoot reconstruction. repair/Coonstration/repair, ulnar or radial collateral ligament reconstruction, biceps tendon reconstruction.

Medial collateral ligament repair, lateral collateral ligament repair, posterior Knee: oblique ligament repair, joint capsule closure, illiotibial band tendodesis, and patellar ligament/tendon repair.

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

Over-The-Counter Use __ NO (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CC:NTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (QRE)

Hulst Vemer
(Division Sign. Off.)

Division of General, Restorative, and Neurological Devices

Page 1 of 1
510(k) Number K061850

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.