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.

AI/ML Overview

Unfortunately, the provided text does not contain information about acceptance criteria, device performance, or any studies conducted on the Signal Medical Corporation Acetabular Component. The documents primarily focus on the 510(k) submission and FDA clearance process, detailing the device description, indications for use, and a letter confirming substantial equivalence to a predicate device.

Therefore, I cannot provide the requested information, including the table of acceptance criteria, study details, sample sizes, ground truth establishment, or multi-reader multi-case study results.

Summary

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OCT 2 4 1997

<971018

510K SUMMARY OF SAFETY AND EFFECTIVENESS

Indications for use

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

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 4 1997

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

Re: K971018 SMC Acetabular Cup Trade Name: 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 requlations.

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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 (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.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 (ORE)

tte

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Prescription Use_ X Counter Use (Per 21 CFR 801.109)

Over-The-

(Optional Format

Regulation Number and Section

§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.

(a)
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.(b)
Classification. Class II.