TRI-LOCK HIP STEM

K001982 · DePuy Orthopaedics, Inc. · LPH · Jul 26, 2000 · Orthopedic

Device Facts

• Record ID: K001982
• Device Name: TRI-LOCK HIP STEM
• Applicant: DePuy Orthopaedics, Inc.
• Product Code: LPH · Orthopedic
• Decision Date: Jul 26, 2000
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3358
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where is evidence of sufficient sound bone to seat and support the components. Total hip replacement is indicated in the following conditions: 1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia. 2. Avascular necrosis of the femoral head. 3. Acute traumatic fracture of the femoral head or neck. 4. Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis. hemiarthroplasty, surface replacement arthroplasty, or total hip replacement. 5. Certain cases of ankylosis.

Device Story

Tri-Lock Hip Stem is a modular, porous-coated femoral component for cementless total hip arthroplasty. Device consists of a femoral stem and a modular head that locks onto the stem; head articulates with an acetabular cup. Used by orthopedic surgeons in clinical settings to replace damaged hip joints. By replacing the articulation, the device aims to restore patient mobility and reduce pain. The system relies on mechanical fixation within the femoral canal.

Clinical Evidence

No clinical data provided; substantial equivalence based on design control activities and comparison to predicate.

Technological Characteristics

Modular femoral hip stem and head manufactured from ASTM F-75 CoCr alloy. Features porous coating for cementless fixation. Designed for use in total hip arthroplasty.

Indications for Use

Indicated for patients requiring total hip arthroplasty due to severe joint pain/disability from osteoarthritis, traumatic arthritis, rheumatoid arthritis, congenital hip dysplasia, avascular necrosis of the femoral head, acute traumatic fracture of the femoral head/neck, failed previous hip surgery, or ankylosis, provided sufficient sound bone exists to support components.

Regulatory Classification

Identification

A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across the joint. This generic type of device has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.

Predicate Devices

• Tri-Lock Hip Stem (cleared 03-18-98)

Submission Summary (Full Text)

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# JUL 2 6 2000

## SUMMARY OF SAFETY AND EFFECTIVENESS

NAME OF FIRM:

DePuy Orthopaedics, Inc. P.O. Box 988 700 Orthopaedic Drive Warsaw, IN 46581-0988

510(k) CONTACT:

Arlene C. Saull. RAC Senior Regulatory Associate

Tri-Lock® Hip Stem

Hip prosthesis

TRADE NAME:

COMMON NAME:

CLASSIFICATION:

888.3358 Hip joint metal/polymer semi-constrained cementless prosthesis

00198

DEVICE PRODUCT CODE:

87 LPH Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented

#### SUBSTANTIALLY EQUIVALENT DEVICES:

Tri-Lock® Hip Stem, cleared via 510(k) on 03-18-98

#### DEVICE DESCRIPTION AND INTENDED USE:

The Tri-Lock Hip Stem is porous coated and intended for cementless use in total hip arthroplasty.

Total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where is evidence of sufficient sound bone to seat and support the components. Total hip replacement is indicated in the following conditions:

- 1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia.
- 2. Avascular necrosis of the femoral head.
- 3. Acute traumatic fracture of the femoral head or neck.
- 4. Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis. hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
- 5. Certain cases of ankylosis.

The Tri-Lock Hip Stem is part of a modular system for use in total hip replacement. The femoral component is provided as two separate units, a porous coated femoral hip stem manufactured from ASTM F-75 CoCr and a modular head also manufactured from ASTM F-75 CoCr. which locks onto the femoral hip stem. The modular head articulates with an acetabular cup of an appropriate diameter.

#### BASIS OF SUBSTANTIAL EQUIVALENCE:

The Tri-Lock Hip Stem has the following similarities to the previously cleared Tri-Lock Hip Stems that were cleared in 1998; same intended use; same method of manufacture; same design; same sterilization and packaging methods. The Tri-Lock Hip Stem demonstrated adequate performance in design control activities.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JUL 2 6 2000

Ms. Arlene C. Saull. RAC Senior Regulatory Associate Depuy Orthopaedics Incorporated P.O. Box 988 700 Orthopaedic Drive Warsaw, Indiana 46581-0988

Re: K001982

Trade Name: Tri-Lock 6.3 mm Hip Stem Regulatory Class: II Product Code: LPH Dated: February June 23, 2000 Received: June 29, 2000

Dear Ms. Saull:

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 control provisions of the Act. The general control 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 (Premarket Approval), 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 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 action. In addition, FDA may publish further announcements 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.

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 legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

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Page 2 - Ms. Arlene C. Saull, RAC

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic 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 at [phone], or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Donna R. Lochner.

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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### 510(k) Number (if known)

## Device Name: Tri-Lock® Hip Stem

#### Indications for Use:

Total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where is evidence of sufficient sound bone to seat and support the components. Total hip replacement is indicated in the following conditions:

- A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, 1. rheumatoid arthritis, or congenital hip dysplasia.
- Avascular necrosis of the femoral head. 2.
- Acute traumatic fracture of the femoral head or neck. 3.
- Failed previous hip surgery including joint reconstruction, internal fixation, 4. arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
- న్. Certain cases of ankylosis. ·

Concurrence of CDRH, Office of Device Evaluation:

Dama R. Lochner.

Division Sign-Off) Jivision of General Resorativ 510(k) Number_KO019

Prescription Use

OR

Over-The Counter Use (Per 21 CFR 801.109)