Indications for the LactoSorb® Screw Anchor with Lactocarbonate Suture includes the 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 tenodesis, 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 collateral ligament repair, posterior oblique repair, joint capsule closure, iliotibial band tenodesis, and patellar ligament/tendon repair.

Device Description

The LactoSorb® Screw Anchor's are resorbable suture anchors used to reattach soft tissue to bone. The anchors consist of a screw portion and a head portion engages with the bone while the head portion provides a means to drive the anchor into the bone.

Lactocarbonate Suture, undyed (white) or dyed (violet), is a synthetic resorbable sterile surgical suture. The suture is a braided size 2 suture.

AI/ML Overview

The Biomet LactoSorb® Screw Anchor with Lactocarbonate Suture (K032072) did not include a study to prove acceptance criteria for device performance. Instead, the submission relies on non-clinical testing for biocompatibility and functionality to demonstrate substantial equivalence to predicate devices.

Here's a breakdown of the requested information based on the provided document:

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

Acceptance Criteria	Reported Device Performance
Biocompatibility (General requirement for implantable devices)	"Results indicated that the device was highly biocompatible."
Functionality (Ability to perform intended use)	"Results indicated that the device... was functional within its indicated uses."

2. Sample sized used for the test set and the data provenance

Sample Size for Test Set: Not applicable. No clinical test set was used.
Data Provenance: Not applicable. Non-clinical (laboratory) testing was performed. The document doesn't specify the country of origin for the lab testing, but the applicant is based in the USA. The testing was prospective for the purpose of this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. No clinical test set requiring expert ground truth was performed.

4. Adjudication method for the test set

Not applicable. No clinical test set was performed.

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 surgical implant, not an AI-assisted diagnostic tool. No MRMC study was conducted.

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

Not applicable. This device is a surgical implant, not an algorithm.

7. The type of ground truth used

For the non-clinical testing, the "ground truth" was established by standard laboratory methods and specifications for biocompatibility and functional performance for resorbable sutures and anchors.

8. The sample size for the training set

Not applicable. No algorithm or AI component requiring a training set is involved with this device.

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

Not applicable. No algorithm or AI component requiring a training set is involved with this device.

Study Proving Acceptance Criteria:

The study that "proves the device meets the acceptance criteria" is described as:

Nonclinical Testing: "Nonclinical laboratory testing was performed to determine substantial equivalence. Biocompatibility and Functionality testing was conducted to assess the safety and effectiveness of Lactocarbonate suture (L-lactide / trimethylene carbonate, dyed and undyed. Results indicated that the device was highly biocompatible and was functional within its indicated uses."

This indicates that the manufacturer performed in-house or contracted laboratory tests to assess critical material properties and mechanical performance relevant to the device's intended use and biological interaction. The specific details of these tests (e.g., test standards, number of samples, specific quantitative results) are not provided in this 510(k) summary but would have been part of the full submission.

Absence of Clinical Testing:

The document explicitly states: "Clinical Testing: None provided as a basis for substantial equivalence." This means the FDA's clearance was based solely on the non-clinical (laboratory) evidence and the device's substantial equivalence to previously cleared predicate devices with established safety and effectiveness.

Summary

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OCT = 1 2003

K032072

Image /page/0/Picture/2 description: The image shows the logo for Biomet Orthopedics, Inc. The word "BIOMET" is written in large, bold, block letters. Below the word "BIOMET" is the text "ORTHOPEDICS, INC." in a smaller font. The logo is simple and professional, and it is likely used on the company's products and marketing materials.

510(k) Summary

Applicant/Sponsor:	Biomet Orthopedics, Inc.P.O. Box 587Warsaw, Indiana 46581-0587
Contact Person:	Tracy J. BickelTelephone: (574) 267-6639Fax: (574) 372-1683
Proprietary Name:	LactoSorb® Screw Anchor with Lactocarbonate Suture
Common Name:	Resorbable Suture and Screw
Classification Name:	Fastener, Fixation, Biodegradable Soft tissue; 87 MAI

Legally Marketed Devices To Which Substantial Equivalence Is Claimed:

Biomet's LactoSorb® L15 Screw Anchor (K012872), Ethicon's Mitek Panalok Suture Anchor System (K970396), and Biomet's LactoSorb® L18 Screw Anchor (K003273).

Device Description:

Lactocarbonate Suture, undyed (white) or dyed (violet), is a synthetic resorbable sterile surgical suture. The suture is a braided size 2 suture.

Intended Use:

Shoulder: Bankart repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule repair or capsulolabral reconstruction, biceps tenodesis, 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 econstruction.

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

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

SHIPPING ADDRESS 56 E. Bell Drive Warsaw, IN 46582

이

( )FFICE 574.267.6639

FAX 574.267.8137

II.-MAIL biomet@biomet.com

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Page 242

510(k) Summary LactoScrb® Screw Anchor with Lactocarbonate Suture E iomet, Inc. F age 2

Summary of Technologies:

™ he technological characteristics (materials, design sizes, and indications) are similar to or identical to that of the predicate devices.

Non-Clinical Testing: Nonclinical laboratory testing was performed to determine substantial • quivalence. Biocompatibility and Functionality testing was conducted to assess the safety and >ffectiveness of Lactocarbonate suture (L-lactide / trimethylene carbonate, dyed and undyed. Results ndicated that the device was highly biocompatible and was functional within its indicated uses.

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

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird-like figure.

Public Health Service

OCT - 1 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Arthrotek, Inc. c/o Ms. Tracy J. Bickel Regulatory Associate Biomet Orthopedic, Inc. P.O. Box 587 Warsaw, Indiana 46581-0587

Re: K032072

Trade/Device Name: LactoSorb® L15 Screw Anchor with Lactocarbonate Suture Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: July 1, 2003 Received: July 3, 2003

Dear Ms. Bickel:

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 - Ms. Tracy J. Bickel

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 N. Millenson

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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Page 1 of 1

510(k) Number (if known): Device Name: LactoSorb® Screw Anchor with Lactocarbonate Suture Indications for Use:

I ndications for the LactoSorb® Screw Anchor with Lactocarbonate Suture includes the u se 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 tenodesis, deltoid repair.

Wrist/Hand: Scapholunate ligament reconstruction, ulnat/radial collateral ligament reconstruction.

stabilization, medial stabilization, Ankle/Foot: Lateral 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 repair, joint capsule closure, iliotibial band tenodesis, and patellar ligament/tendon repair.

for Mark N. Milliken
(Division Sign-Off)

Division of Ger end, Restorative and Neurological Devices

510(k) Number K032072

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use No
(Optional Format 1-2-96)

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.