LIGAFIX® are resorbable cannulated screws made of ceramic (β-ΤCP) / polymer (Poly Lactic Acid) composite and designed for the interference fixation of grafts in anterlor cruciate ligament reconstruction.

To better fit the surgeon's needs and surgical preferences and patient's anatomy the full range of LIGAFIX Interference screws comprise:

2 material specifications: LIGAFIX® 30 (30% TCP/70% PLA) and LIGAFIX® 60 (60% o TCP/40% PLA)
3 head design: standard reduced -- rounded ಂ
Diameters from 7 mm to 11 mm 0
Lengths from 20 mm to 35 mm ಂ

LIGAFIX® interference screws are supplied sterile and individually packaged In double heat sealed pouches.

AI/ML Overview

This 510(k) Special submission is for an extension of the range of products for the LIGAFIX® Resorbable Interference Screw. It focuses on demonstrating substantial equivalence to previously cleared devices (K050407 and K061262) rather than presenting a de novo study with new acceptance criteria and performance data for a novel device.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment, which are typical for studies validating the performance of a new device, are largely not applicable in the context of this specific 510(k) submission.

This submission asserts that the expanded product range (new material specifications, head designs, diameters, and lengths) of the LIGAFIX® Interference Screws shares the "same fundamental scientific technology, operating principle and intended use" as the predicate devices. The review process for such a submission typically involves evaluating whether the new product variations introduce any new questions of safety or effectiveness that would necessitate new performance studies. Since this document is a 510(k) summary, it doesn't contain detailed study reports.

Here's a breakdown of why most of the requested points cannot be answered from the provided text, and what can be inferred:

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

Not Applicable in this context. The document does not provide a table of acceptance criteria or reported device performance for a new study. The submission relies on the substantial equivalence to previously cleared devices which would have undergone performance testing during their initial clearance. The "performance" being demonstrated here is the similarity to the predicate devices.

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

Not Applicable. No new test set or associated data provenance is mentioned as this is a Special 510(k) for an expansion of an existing device line, not a new device requiring a new clinical or performance study.

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 test set or ground truth establishment by experts is described in this submission.

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

Not Applicable. No test set or adjudication method is described.

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 resorbable interference screw, not an AI-powered diagnostic or assistive technology. Therefore, MRMC studies or AI-related effectiveness are entirely irrelevant.

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

Not Applicable. As above, this is a physical medical device, not an algorithm.

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

Not Applicable. No new ground truth is established for this submission. The "ground truth" for the clearance of the predicate devices would have been based on established engineering principles, biocompatibility testing, mechanical testing, and potentially animal or clinical studies to demonstrate safety and effectiveness for their intended use.

8. The sample size for the training set

Not Applicable. This is not an AI/machine learning device; thus, there is no "training set."

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

Not Applicable. No training set is involved.

Summary

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Ko7o5o7

SPECIAL 510k

LIGAFIX® Interference screws

Image /page/0/Picture/3 description: The image shows the words "Science for Bio Materials" in a stylized font. The word "Science" is in a smaller font than the words "Bio Materials". There are three right-pointing triangles to the right of the words. The words "Science for Bio Materials" are underlined.

MAR 2 9 2007 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

1. GENERAL INFORMATION

Trade Name	LIGAFIX® Resorbable Interference Screw
Common Name	Bone Fixation Screw
Classification Name	Screw, Fixation, Bone
Class	II
Product Code	HWC
CFR section	21CFR 888.3040
Device panel	Orthopedic
Legally marketed predicatedevices	LIGAFIX® Resorbable Interference Screw K050407 and K061262
Reason for special 510k	Extension of the range of products
Submitter	SCIENCE FOR BIOMATERIALSSciences et Bio MatériauxZI du MongeF 65100 LOURDES - FRANCEOwner operation Number : 9063735
Contact	Denis CLEMENT, General ManagerTel : +33 (0)5 62 42 21 01Fax : +33 (0)5 62 42 21 00e-mail : denis.clement@sbm-fr.comRegulatory contact: Idée Consulting (FRANCE)Isabelle DRUBAIX e-mall : idrubaix@nordnet.fr

2. DEVICE DESCRIPTION

To better fit the surgeon's needs and surgical preferences and patient's anatomy the full range of LIGAFIX Interference screws comprise:

2 material specifications: LIGAFIX® 30 (30% TCP/70% PLA) and LIGAFIX® 60 (60% o TCP/40% PLA)
3 head design: standard reduced -- rounded ಂ
Diameters from 7 mm to 11 mm 0
Lengths from 20 mm to 35 mm ం

Page 79/82

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12/11/12

Page 2 of 2

SPECIAL 510k

LIGAFIX® Interference screws

SCIENCE FOR BIO MATERIALS

LIGAFIX® interference screws are supplied sterile and individually packaged In double heat sealed pouches.

3. INTENDED USE

"LigaFix® interference screws are designed for the interference fixation of grafts in anterior cruclate ligament reconstruction."

4. SUBSTANTIAL EQUIVALENCE

The additional LIGAFIX® Interference screws have the same fundamental scientific technology, operating principle and intended use as previously cleared LIGAFIX® Interference screw K050407 and K061262.

Summary preparation date: February 13, 2007

Page 80/82

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DEPARTMENT OF HEALTH & HUMAN SERVICES - USA

ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 9 2007

Science For Biomaterials % Mr. Denis Clement General Manager ZI du Monge F 65100 LOURDES, FRANCE

Re: K070507

Trade/Device Name: Ligafix® Resorbable Interference Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: February 16, 2007 Received: February 27, 2007

Dear Mr. Clement:

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. Denis Clement

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 (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/cdrb/industry/support/index.html.

Sincerely yours,

Harbare Buellio

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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SPECIAL 510k LIGAFIX® Interference screws

SCIENCE FOR BIO MATERIALS

Indications for Use

510(k) Number (if known):

K070507

Device Name: LIGAFIX® RESORBABLE INTERFERENCE SCREW

Indications for Use;

"LigaFix® interference screws are designed for the interference fixation of grafts in anterior cruciate ligament reconstruction."

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

Over-The-Counter Use No

(21 CFR 801 Subpart C)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Aubare bucher

Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number K07507

Page 72 / 82

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.