(396 days)
Interlocking hip stems are indicated for non-cemented application in cases of revision, trauma, fracture, oncology or other situations where severe proximal bone loss may compromise the fixation and stability of a standard type hip replacement prosthesis.
The Interlocking Hip Stems are metallic femoral stems with transverse screw holes in the distal portion. These devices offer a combination of total hip replacement with the benefits of an intramedullary nail. Each stem has three medial/lateral slots.
Two styles of stems are available. The first geometry is that of a Mallory/Head Calcar device. This device provides head/neck replacement to compensate for bone deficiencies in the proximal/medial portion of the femur. The second style of stem is that of Biomet's Bi-Metric device. This device has a bi-planner taper which promotes increased proximal off-loading and filling of the metaphysis. The device has a collar.
The cross-screws are available in lengths of 25mm to 60mm and 5mm diameters. Only the end of the screw is threaded so that the portion of the screw that resides inside the stem is smooth.
The femoral stems are manufactured from titanium alloy (Ti-6A1-4V) conforming to ASTM F-620. The cross-screws are manufactured from Ti-6Al-4V conforming to ASTM F-136.
The provided text is a summary of safety and effectiveness for a medical device (Interlocking Hip Stems) undergoing a 510(k) premarket notification process for the FDA. It does not contain information about acceptance criteria, device performance results from a study, sample sizes, expert qualifications, or ground truth establishment relevant to an AI/ML powered device.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set and data provenance.
- Number of experts used and their qualifications.
- Adjudication method.
- MRMC comparative effectiveness study results.
- Standalone performance information.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
This document describes a traditional medical device submission, focusing on device description, materials, indications for use, potential risks, and substantial equivalence to a predicate device. It is not an evaluation of an AI/ML algorithm's performance.
{0}------------------------------------------------
APR 1 1 2000
Image /page/0/Picture/2 description: The image shows the logo for BIOMET INC. The logo is in black and white, with the word "BIOMET" in large, bold letters. The letters are stylized, with the "B" and "T" having a boxy appearance. The letters "INC" are stacked vertically to the right of the word "BIOMET" in a smaller font.
CORPORATE HEADQUARTERS
SUMMARY OF SAFETY AND EFFECTIVENESS
| Proprietary Name: | Mallory/Head Calcar Replacement with Interlocking SlotsBi-Metric Porous Collared Stem with Interlocking Slots |
|---|---|
| Classification Name: | Prosthesis, hip, semi-constrained, metal/polymer, porous, uncemented(888.3558) |
Device Classification: Class II
Device Product Code: 87LPH
Indications for Use: Interlocking hip stems are indicated for non-cemented application in cases of revision, trauma, fracture, oncology or other situations where severe proximal bone loss may compromise the fixation and stability of a standard type hip replacement prosthesis.
Device Description: The Interlocking Hip Stems are metallic femoral stems with transverse screw holes in the distal portion. These devices offer a combination of total hip replacement with the benefits of an intramedullary nail. Each stem has three medial/lateral slots.
Two styles of stems are available. The first geometry is that of a Mallory/Head Calcar device. This device provides head/neck replacement to compensate for bone deficiencies in the proximal/medial portion of the femur. The second style of stem is that of Biomet's Bi-Metric device. This device has a bi-planner taper which promotes increased proximal off-loading and filling of the metaphysis. The device has a collar.
The cross-screws are available in lengths of 25mm to 60mm and 5mm diameters. Only the end of the screw is threaded so that the portion of the screw that resides inside the stem is smooth.
The femoral stems are manufactured from titanium alloy (Ti-6A1-4V) conforming to ASTM F-620. The cross-screws are manufactured from Ti-6Al-4V conforming to ASTM F-136.
Potential Risks: The potential risks associated with this device are the same as with any joint replacement device. These include, but are not limited to:
Fracture of the component Implant loosening/migration Blood vessel damage Breakdown of porous surface Nerve damage Tissue ingrowth failure
Deformity of the ioint Delayed wound healing Metal sensitivity Soft tissue imbalance Cardiovascular disorders Fracture of Screws
Bone fracture Hematoma Infection Dislocation Excessive wear
MAILING ADDRESS 120. 130x 587 Warsaw, IN 46581-0587
1
SHIPPING ADDRESS Airport Industrial Park Warsaw, IN 46580
()FFICE 219.267.6639
FAX 219.267.81 37
E-MAIL biomet@biomet.com
{1}------------------------------------------------
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 1 2000
Ms. Patricia Sandborn Beres Senior Regulatory Specialist Biomet, Inc. P.O. Box 587 Warsaw, Indiana 46581-0587
Re: K990830/S2 Trade Name: Interlocking Hip Stems Regulatory Class: II Product Code: LPH Dated: January 14, 2000 Received: January 18, 2000
Dear Ms. Beres:
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.
{2}------------------------------------------------
Page 2 - Ms. Patricia Sandborn Beres
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 at (301) 443-6597, 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 and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
Page 1 of 1
510(k) Number (if known): K990830
Device Name: Interlocking Hip Stems
Indications For Use:
Interlocking hip stems are indicated for non-cemented application in cases of revision, trauma, fracture, oncology or other situations where severe proximal bone loss may compromise the fixation and stability of a standard type hip replacement prosthesis.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation
Dunner inel. (Division Sign-Off) Jivision of General Restorative Devices
510(k) Number_k990830
Over-The-Counter Use
(Optional Format 1-2-96)
Prescription Use (Per 21 CFR 801.1091 OR
§ 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.