SMC ACETABULAR COMPONENT

K971018 · Signal Medical Corp. · LPH · Oct 24, 1997 · Orthopedic

Device Facts

• Record ID: K971018
• Device Name: SMC ACETABULAR COMPONENT
• Applicant: Signal Medical Corp.
• Product Code: LPH · Orthopedic
• Decision Date: Oct 24, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3358
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Osteoarthritis Rheumatoid Arthritis Traumatic Arthritis Where the use of a more conservative procedure has failed or is unacceptable.

Device Story

SMC Acetabular Component is a prosthetic hip implant component. It consists of a forged titanium (Ti-6Al-4V ELI) shell available in 13 sizes (48mm-72mm). The exterior features a commercially pure titanium sintered beaded surface for bone ingrowth or cement adherence; three circumferential pins provide primary skeletal fixation and rotational stability. The internal assembly, including the locking ring, three pegs, and ultra-high molecular weight polyethylene (UHMWPE) insert, is identical to the StelKast Proform Porous Acetabular Assembly. The device is designed to accept 28mm femoral heads. It is used by orthopedic surgeons during total hip arthroplasty to replace diseased or damaged acetabular surfaces, aiming to restore joint function and reduce pain for patients with degenerative or traumatic arthritis.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design, material, and component identity to the predicate device.

Technological Characteristics

Materials: Forged titanium (Ti-6Al-4V ELI, ASTM F-136, F620) shell; commercially pure titanium sintered beaded surface; UHMWPE insert. Dimensions: 13 sizes, 48mm to 72mm. Fixation: Sintered beads and three circumferential pins. Internal locking: Ring and three-peg system. Designed for 28mm femoral heads.

Indications for Use

Indicated for patients with osteoarthritis, rheumatoid arthritis, or traumatic arthritis where conservative procedures have failed or are unacceptable.

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

• StelKast Corporation Proform Porous Acetabular Assembly (K950827)

Submission Summary (Full Text)

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OCT 24 1997
K971018

# 510K SUMMARY OF SAFETY AND EFFECTIVENESS

The Signal Medical Corporation Acetabular Component is manufactured of forged titanium, 6 aluminum, 4 vanadium, ELI metal (ASTM F-136, F620). The design is made available in thirteen (13) sizes ranging from 48mm to 72mm. The outside diameter of the cup is coated with a commercially pure titanium sintered beaded surface to enhance either bone ingrowth or cement adherence depending on the choice of the surgeon. Also three circumferentially spaced pins or spikes at 120 degree intervals provide for a primary skeletal fixation and reduce the chance of rotation. The inside assembly of the device and the polyethylene insert are identical to the StelKast Corporation Proform Porous Acetabular Assembly (K950827). The inside diameter system provides a locking ring and three pegs that secure the ultra high molecular weight polyethylene articular surface in place. The acetabular inserts are identical to the StelKast Corporation (K950827) inserts. The ultra high molecular weight polyethylene inserts are secured to the acetabular shell as described above and are designed to accept 28mm femoral heads on their inside diameter.

## Indications for use

1. Osteoarthritis
2. Rheumatoid Arthritis
3. Traumatic Arthritis
4. Where the use of a more conservative procedure has failed or is unacceptable.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

Louis A. Serafin, Jr., M.D.
President
Signal Medical Corporation
3315 Berry Drive
Lakeport, Michigan 48059

OCT 24 1997

Re: K971018
Trade Name: SMC Acetabular Cup
Regulatory Class: II
Product Code: LPH
Dated: July 30, 1997
Received: August 5, 1997

Dear Dr. Serafin:

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 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 (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.

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Page 2 - Louis A. Serafin, Jr., M.D.

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.

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 [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,


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

Enclosure

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Page 1 of 1

510(k)Number(ifknown): K971018

Device Name: **SMC ACETABULAR COMPONENT**

Indications For Use:

- Osteoarthritis
- Rheumatoid Arthritis
- Traumatic Arthritis
- Where the use of a more conservative procedure has failed or is unacceptable

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)


Prescription Use ☑
Counter Use ☐
(Per 21 CFR 801.109)

OR Over-The- (Optional Format)