The DePuy Interference Screw Systems are intended to be used to provide interference fixation of bone-patellar tendon-bone grafts in anterior cruciate ligament (ACL) and posterior cruciate ligament (PCL) reconstruction and of soft tissue grafts in ACL reconstruction.

Device Description

The DePuy Interference Screw Systems are cannulated fully threaded cancellous bone screws available in three diameters (7, 8, and 9mm) in three lengths (20, 25,and 30mm), and manufactured from titanium alloy (DePuy Profile Round Head Interference Screw) and from Poly-L-lactic acid (DePuy Phantom Absorbable Interference Screw).

AI/ML Overview

Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Implicit)	Reported Device Performance
Mechanical properties (specifically pull-out loads) comparable to previously cleared predicate devices for PCL reconstruction.	"Mechanical testing has shown that the mean pull-out loads of the Profile Round Head Interference Screws and the Phantom Absorbable Interference Screws are comparable to those published for the previously cleared Linvatec BioScrew indicated for interference fixation in PCL reconstruction." The submission states that the DePuy devices are "identical in design and materials" to their own previously cleared devices (K955733, K981670, K961234), with the only difference being the additional indication for PCL reconstruction. This implies that the design and material properties relevant to the new indication are sufficiently similar or demonstrated to be comparable through testing.

Acceptance Criteria (Implicit)

Reported Device Performance

Mechanical properties (specifically pull-out loads) comparable to previously cleared predicate devices for PCL reconstruction.

"Mechanical testing has shown that the mean pull-out loads of the Profile Round Head Interference Screws and the Phantom Absorbable Interference Screws are comparable to those published for the previously cleared Linvatec BioScrew indicated for interference fixation in PCL reconstruction." The submission states that the DePuy devices are "identical in design and materials" to their own previously cleared devices (K955733, K981670, K961234), with the only difference being the additional indication for PCL reconstruction. This implies that the design and material properties relevant to the new indication are sufficiently similar or demonstrated to be comparable through testing.

Sample Size for Test Set and Data Provenance:
The document does not specify the exact sample size used for the mechanical testing. The data provenance is not explicitly stated in terms of country of origin, but the testing was conducted to support a submission to the FDA (United States). The testing appears to be prospective, as it was conducted to demonstrate substantial equivalence for a new indication.
Number of Experts and Qualifications:
Not applicable. This is a medical device submission based on mechanical testing and substantial equivalence, not a study requiring expert readers for image or data interpretation.
Adjudication Method:
Not applicable for this type of submission.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not done. This submission focuses on the mechanical equivalence of a new indication for a medical device through lab testing, not human performance with AI assistance.
Standalone Performance:
Yes, a standalone performance assessment was conducted in the form of mechanical testing of the device's pull-out loads. The performance was assessed independently of human interaction during the test.
Type of Ground Truth Used:
The "ground truth" in this context is the established mechanical performance (pull-out loads) of a legally marketed predicate device (Linvatec BioScrew) for PCL reconstruction, as presented in published literature. The DePuy devices' performance was compared against this established benchmark.
Sample Size for Training Set:
Not applicable. This is a medical device submission based on mechanical testing and substantial equivalence. There is no "training set" in the context of an algorithm or AI.
How Ground Truth for Training Set Was Established:
Not applicable, as there is no training set. The comparison was made against published data for a predicate device.

Summary

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OCT 28 1998

K982662

SUMMARY OF SAFETY AND EFFECTIVENESS

NAME OF FIRM:	DePuy, Inc.P.O. Box 988700 Orthopaedic DriveWarsaw, Indiana 46581-0988
FIRM CONTACT:	Sally FoustSenior Regulatory Submissions Associate
TRADE NAME:	DePuy Profile™ Round Head Interference ScrewDePuy Phantom™ Resorbable Interference Screw
COMMON NAME:	Bone Screw
CLASSIFICATION:	888.3040 Smooth or threaded metallic bone fixation fastener
DEVICE PRODUCT CODE:	87 HWC and MAI

SUBSTANTIALLY EQUIVALENT DEVICES:

•DePuy Phantom Absorbable Interference Screw (K955733, K981670) •DePuy Profile Round Head Interference Screw (K961234, K981670) ·Linvatec BioScrew Absorbable Interference Screw (K960652, K960940)

DEVICE DESCRIPTION AND INTENDED USE: The DePuy Interference Screw Systems are cannulated fully threaded cancellous bone screws available in three diameters (7, 8, and 9mm) in three lengths (20, 25,and 30mm), and manufactured from titanium alloy (DePuy Profile Round Head Interference Screw) and from Poly-L-lactic acid (DePuy Phantom Absorbable Interference Screw).

The DePuy Interference Screw Systems are intended to provide interference fixation of bone-patellar tendon-bone grafts in ACL and PCL reconstruction and of soft tissue grafts in ACL reconstruction.

BASIS OF SUBSTANTIAL EQUIVALENCE:

The DePuy Profile Round Head and the Phantom Absorbable Interference Screws are identical in design and materials to the DePuy Profile Round Head and Phantom Absorbable Interference screws which have been previously been cleared by FDA for interference fixation of bone-patellar tendon-bone grafts in ACL reconstruction and of soft tissue grafts in ACL reconstruction. The only difference between this submission and the previously cleared submission is the additional indication for interference fixation of bone-patellar tendon-bone grafts in PCL reconstruction.

Mechanical testing has shown that the mean pull-out loads of the Profile Round Head Interference Screws and the Phantom Absorbable Interference Screws are comparable to those published for the previously cleared Linvatec BioScrew indicated for interference fixation in PCL reconstruction.

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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized human figure with three wavy lines representing the body. The figure is enclosed in a circle of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 28 1998

Ms. Sally Foust Senior Regulatory Submissions Associate DePuy Orthopaedics, Inc. P.O. Box 988 700 Orthopaedic Drive Warsaw, Indiana 46581-0988

K982662 Re: DePuy Profile Round Head Interference Screw Trade Name: and DePuy Phantom Interference Screw II Regulatory Class: Product Codes: HWC, MBI, and MAI Dated: July 29, 1998 Received: July 30, 1998

Dear Ms. Foust:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Ms. Sally Foust

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a leqally 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 809.10 for in vitro diaqnostic 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.qov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D.
Director

Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known) (982622

Device Name DePuy Interference Screw Systems - Additional Indication/Intended Use to Provide Interference Fixation of Bone-Patellar Tendon-Bone Grafts in Posterior Cruciate Ligament (PCL) Reconstruction

Indications for Use:

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Concurrence of CDRH, Office of Device Evaluation

boceto

(Division Division of General Restora 510(k) Number

Prescription Use_ X (Per 21 CFR 801.109)

Over-The-Counter Use

0000002

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.