DEPUY PROFILE ROUND HEAD INTERFERENCE SCREW, DEPUY PHANTOM RESORBABLE INTERFERENCE SCREW

K982662 · DePuy Orthopaedics, Inc. · HWC · Oct 28, 1998 · Orthopedic

Device Facts

• Record ID: K982662
• Device Name: DEPUY PROFILE ROUND HEAD INTERFERENCE SCREW, DEPUY PHANTOM RESORBABLE INTERFERENCE SCREW
• Applicant: DePuy Orthopaedics, Inc.
• Product Code: HWC · Orthopedic
• Decision Date: Oct 28, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 Story

DePuy Interference Screw Systems consist of cannulated, fully threaded cancellous bone screws; available in 7, 8, and 9mm diameters and 20, 25, and 30mm lengths. Manufactured from titanium alloy (Profile Round Head) or Poly-L-lactic acid (Phantom Absorbable). Used by surgeons in orthopedic procedures for ACL and PCL reconstruction. Screws provide mechanical interference fixation of bone-patellar tendon-bone or soft tissue grafts within bone tunnels. Device functions as a fixation fastener to secure grafts during ligament reconstruction, facilitating healing and joint stability.

Clinical Evidence

No clinical data. Substantial equivalence supported by mechanical pull-out load testing comparing subject devices to the predicate Linvatec BioScrew.

Technological Characteristics

Cannulated, fully threaded cancellous bone screws. Materials: Titanium alloy and Poly-L-lactic acid. Diameters: 7, 8, 9mm. Lengths: 20, 25, 30mm. Mechanical fixation principle.

Indications for Use

Indicated for interference fixation of bone-patellar tendon-bone grafts in ACL and PCL reconstruction and soft tissue grafts in ACL reconstruction.

Regulatory Classification

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.

Predicate Devices

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

Submission Summary (Full Text)

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OCT 28 1998

K982662

#### SUMMARY OF SAFETY AND EFFECTIVENESS

| NAME OF FIRM: | DePuy, Inc.<br>P.O. Box 988<br>700 Orthopaedic Drive<br>Warsaw, Indiana 46581-0988 |
|----------------------|----------------------------------------------------------------------------------------------|
| FIRM CONTACT: | Sally Foust<br>Senior Regulatory Submissions Associate |
| TRADE NAME: | DePuy Profile™ Round Head Interference Screw<br>DePuy 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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:

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.

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

boceto

(Division Division of General Restora 510(k) Number

Prescription Use_ X (Per 21 CFR 801.109)

OR

Over-The-Counter Use

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