RESORBABLE NO PROFILE SCREW AND WASHER by BIOMET MANUFACTURING, INC.

ACL and PCL reconstruction
Medial collateral ligament repair
Lateral collateral ligament repair
Posterior oblique ligament repair
Iliotibial band tenodesis reconstruction
Patellar ligament and tendon repair
This device is also intended to be used as back-up fixation in ACL reconstruction in conjunction with other marketed devices in order to provide additional fixation strength in instances of questionable bone quality.

Device Description

The Resorbable No Profile Screw and Washer consists of a resorbable 6.5 mm screw that varies in length from 25 mm to 55 mm (5 mm increments) and a 18 mm diameter washer. This device is comprised of a PLLA/PGA copolymer. The device was designed to be used in conjunction with marketed devices such as resorbable or allograft interference screws in ACL reconstruction. The purpose of this back-up fixation will be to provide additional fixation strength in instances of questionable bone quality.

AI/ML Overview

The provided 510(k) summary for the "Resorbable No Profile Screw and Washer" explicitly states:

"Clinical Testing: Clinical testing was not used to establish substantial equivalence to predicate devices."

Therefore, the device's acceptance criteria were based on non-clinical testing. Below is an interpretation of the available information based on the typical requirements for a 510(k) submission, particularly when clinical data is absent.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (Inferred)	Reported Device Performance (Inferred from "Summary of Technologies" and "Non-Clinical Testing")
Biocompatibility	The safety of the PLLA/PGA copolymer material in biological environments must be demonstrated. (Typically, this involves ensuring the material is non-toxic, non-allergenic, non-pyrogenic, and does not cause adverse biological reactions).	Implied that the PLLA/PGA copolymer used in the "Resorbable No Profile Screw and Washer" is "similar to or identical to the predicate devices" in terms of materials. This suggests that the biocompatibility has been established for similar materials in existing legally marketed devices.
Mechanical Strength	The screw and washer must exhibit sufficient mechanical strength (e.g., tensile strength, torsional strength, bending strength, pull-out strength, fatigue strength) to withstand physiological loads for the duration of the healing process, comparable to or better than predicate devices.	"Mechanical testing was performed to establish substantial equivalence to the predicate devices." This implies that the device's mechanical properties met the performance standards demonstrated by the predicate devices. The specific values are not provided in this summary, but they would have been within the 510(k) submission.
Degradation Profile	As a resorbable device, its degradation characteristics (rate of resorption, products of degradation) must be well-characterized and shown to be safe and predictable, and comparable to or better than predicate devices made of similar materials.	"This device is comprised of a PLLA/PGA copolymer." This material is known for its resorbable properties. The statement "similar to or identical to the predicate devices" in terms of materials suggests that the degradation profile is also considered equivalent to established devices.
Dimensional Conformity	The specified dimensions (e.g., screw diameter, length range, washer diameter) must be consistently manufactured according to specifications.	"The Resorbable No Profile Screw and Washer consists of a resorbable 6.5 mm screw that varies in length from 25 mm to 55 mm (5 mm increments) and a 18 mm diameter washer." This indicates the specified dimensions. Conformance to these dimensions would have been verified through manufacturing quality controls and potentially inspection.
Sterility	The device must be supplied sterile, and its packaging must maintain sterility until the point of use. (Typically demonstrated via validated sterilization methods and packaging integrity tests).	Not explicitly mentioned but is a standard requirement for implantable devices. Implied to be met, likely through established sterilization methods comparable to predicate devices.
Packaging & Labeling	Labeling must be clear, accurate, and include all necessary information (e.g., indications for use, warnings, contraindications, instructions for use). Packaging must protect the device during transport and storage.	The 510(k) process reviews labeling as part of substantial equivalence. The provided document details the indications for use, device description, and contact information, essential for compliant labeling.
Functional Equivalence	The device must function as intended for its stated indications for use, demonstrating equivalence in performance to predicate devices for its primary and proposed secondary use (back-up fixation).	The "Summary of Technologies" states that the "technological characteristics (materials, design, sizes, and indications) are similar to or identical to the predicate devices." This implies functional equivalence was established through comparison to the predicate devices, supported by the mechanical testing. The additional indication for "back-up fixation in ACL reconstruction in conjunction with other marketed devices in order to provide additional fixation strength in instances of questionable bone quality" suggests it functions effectively in this role.

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

Sample Size: Not applicable. The submission explicitly states "Clinical testing was not used to establish substantial equivalence to predicate devices." For non-clinical (mechanical) testing, sample sizes would typically be determined by statistical methods or industry standards for specific tests (e.g., ISO standards for biomaterials). This information is not provided in the summary.
Data Provenance: Not applicable for clinical data. For non-clinical data, it would typically be generated in a lab setting (e.g., Biomet's own labs or contract testing labs). The document does not specify the origin of the mechanical test data.

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

Not applicable. No clinical testing was performed, so no expert ground truth was established for a clinical test set.

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

Not applicable. No clinical testing was performed.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No. No clinical testing or human reader studies were mentioned or conducted.

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

Not applicable. This is not an AI/algorithm device. It is a physical medical device (screw and washer).

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

Not applicable for clinical ground truth. For non-clinical testing, the "ground truth" or reference for acceptance would be established engineering specifications, mechanical properties of predicate devices, and relevant ISO/ASTM standards for medical implants.

8. The sample size for the training set

Not applicable. This is not an AI/algorithm device that requires a training set.

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

Not applicable. This is not an AI/algorithm device that requires a training set.

In summary: The "Resorbable No Profile Screw and Washer" received 510(k) clearance based on substantial equivalence primarily demonstrated through non-clinical (mechanical) testing and a comparison of technological characteristics (materials, design, sizes, indications) to legally marketed predicate devices. No clinical studies or human performance evaluations were conducted or required for this particular submission.

Summary

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K01246951
Page 1 of 2

DEC 0 3 2001

Image /page/0/Picture/2 description: The image shows the logo for Biomet INC. The logo is in black and white and features the word "BIOMET" in a bold, sans-serif font. The letters are connected to each other, and the "INC" is stacked vertically to the right of the "T". Below the logo, the words "CORPORATE HEADQUARTERS" are printed in a smaller, serif font.

SUMMMARY OF SAFETY AND EFFECTIVENESS

Applicant or Sponsor:	Arthrotek, Inc.(A wholly owned subsidiary of Biomet, Inc.)56 East Bell DriveP.O. Box 587Warsaw, Indiana 46581-0587Establishment Registration No.: 1825034
Contact Person:	Sara B. ShultzBiomet Manufacturing, Corp.P.O. Box 587Warsaw, Indiana 46581-0587Phone: (219) 267-6639FAX: (219) 372-1683
Proprietary Name:	Resorbable No Profile Screw and Washer
Common or Usual Name:	resorbable screw and washer
Classification Name:	Screw, Fixation, Bone, Non-spinal, Non-metallic(888.3040)Washer, Bolt Nut, Non-spinal, Non-metallic(888.3030)

Device Product Code: 87HWC and HTN

Legally Marketed Devices To Which Substantial Equivalence is Claimed: Arthrotek Interference Screw (Biomet, Inc., K982497), Harpoon Suture Anchor (Biomet, Inc., K943806/K973775), Sutureless Anchor (Innovasive Devices, K984490), EndoPearl™ with Threader (Linvatec Corp., K993339)

Indications for Use: The Resorbable No Profile Screw and Washer is indicated for the following procedures:

1. ACL and PCL reconstruction
1. Medial collateral ligament repair
1. Lateral collateral ligament repair
1. Posterior oblique ligament repair
1. Iliotibial band tenodesis reconstruction
1. Patellar ligament and tendon repair

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

SHIPPING ADDRESS Airport Industrial Park Warsaw, IN 46580

OFFICE 219.267.6639

FAX ■

Image /page/0/Picture/18 description: The image shows the number 000250, with the last digit being a 1. The numbers are in a bold, sans-serif font. The image is in black and white.

E-MAIL biomet@biomet.com

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K012469581
page 2 of 2

Image /page/1/Picture/1 description: The image shows the logo for Biomet Inc. The logo consists of the word "BIOMET" in a bold, sans-serif font, with the letters connected to form a single shape. To the right of the word "BIOMET" is the word "INC" in a smaller font, stacked vertically. Below the logo is the phrase "CORPORATE HEADQUARTERS" in a smaller, serif font.

This device is also intended to be used as back-up fixation in ACL reconstruction in conjunction with other marketed devices in order to provide additional fixation strength in instances of questionable bone quality.

Device Description: The Resorbable No Profile Screw and Washer consists of a resorbable 6.5 mm screw that varies in length from 25 mm to 55 mm (5 mm increments) and a 18 mm diameter washer. This device is comprised of a PLLA/PGA copolymer.

The device was designed to be used in conjunction with marketed devices such as resorbable or allograft interference screws in ACL reconstruction. The purpose of this back-up fixation will be to provide additional fixation strength in instances of questionable bone quality.

Summary of Technologies: The Resorbable No Profile Screw and Washer technological characteristics (materials, design, sizes, and indications) are similar to or identical to the predicate devices.

Non-Clinical Testing: Mechanical testing was performed to establish substantial equivalence to the predicate devices.

Clinical Testing: Clinical testing was not used to establish substantial equivalence to predicate devices.

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

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SHIPPING ADDRESS Airport Industrial Park Warsaw, IN 46580

()FFICE 219.267.6639 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

E-MAIL biomet@biomet.com

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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 consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines above two wavy lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 0 3 2001

Biomet Manufacturing, Corporation c/o Ms. Sara B. Shultz Regulatory Specialist P.O. Box 587 Warsaw, Indiana 46581-0587

Re: K012469

Trade/Device Name: Resorbable No Profile Screw and Washer Regulation Number: 888.3040 and 888.3030 Regulation Name: Smooth or Threaded Metallic Bone Fixation Fastener and Single/Multiple Component Metallic Bone Fixation Appliances and Accessories Regulatory Class: Class II Product Code: HWC and HTN Dated: October 24, 2001

Received: October 25, 2001

Dear Ms. Shultz:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed your bection of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreated of the enactment date of the Medical Device Amendments, or to conninerce provision to May 20, 1978, the excordance with the provisions of the Federal Food, Drug, devices that have boon recuire approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I ou may, dicrororo, mains of 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 rr your device is olassined (600 as 10,000) of on the major regulations affecting your device can may or sabject to back as a sateral 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 r tease oe actives and i be reviewan that your device complies with other requirements of the Act

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Page 2 - Ms. Sarah B. Shultz

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 listingPage (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.

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,

b. Mali N. Millison

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

Enclosure

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K0124691

Page _ of _

510(k) NUMBER (IF KNOWN):__KOLA 469

DEVICE NAME: Resorbable No Profile Screw and Washer

INDICATIONS FOR USE:

The Resorbable No Profile Screw and Washer is indicated for the following procedures:

1. ACL and PCL reconstruction
1. Medial collateral ligament repair
1. Lateral collateral ligament repair
1. Posterior oblique ligament repair
1. Iliotibial band tenodesis reconstruction
1. Patellar ligament and tendon repair

(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
(Optional Format 1-2-96)

(Division Sign-Off

Division of General, Restorative and Neurological Devices

510(k) Number

0000003

K01246

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.