PEGGED ACETABULAR COMPONENT
Device Facts
| Record ID | K970501 |
|---|---|
| Device Name | PEGGED ACETABULAR COMPONENT |
| Applicant | Biomet, Inc. |
| Product Code | LPH · Orthopedic |
| Decision Date | Apr 30, 1997 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 888.3358 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Intended Use
The Pegged Acetabular Component is intended for use in reconstruction of the hip joint due to disease, deformity of trauma. The device is intended for cemented application for general use and non-cemented application in skeletally mature individuals undergoing primary surgery for rehabilitating hip joints damaged as a result of non-inflammatory degenerative joint disease or any of its composite diagnoses. The device is a single use implant.
Device Story
Pegged Acetabular Component; hemispherical metallic shell; three superior pegs/spikes for initial fixation and rotational control; porous-coated outer surface. Used with Biomet Ringloc Acetabular Liners and any commercially available femoral component. Implanted by orthopedic surgeons in clinical settings for hip joint reconstruction. Provides mechanical stability and joint articulation; benefits patients by restoring hip function damaged by disease or trauma.
Clinical Evidence
No clinical data provided; substantial equivalence based on design and functional similarity to predicate devices.
Technological Characteristics
Hemispherical metallic shell; three superior fixation pegs; porous-coated outer surface. Designed for use with Ringloc Acetabular Liners and standard femoral components. Single-use implant.
Indications for Use
Indicated for skeletally mature patients undergoing primary hip reconstruction due to disease, deformity, trauma, or non-inflammatory degenerative joint disease. Intended for cemented use generally or non-cemented use in primary surgery.
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
- Universal® Acetabular Component (Biomet)
- Mallory-Head® Acetabular Component (Biomet)
- Reflection™ Porous-Coated Acetabular Component (Richards)
- PCA® Acetabular Component (Howmedica)
- Duraloc™ 300 Acetabular Cup System (DePuy)
Related Devices
- K000254 — PAR 5 ACETABULAR COMPONENT · Biomet, Inc. · Feb 7, 2000
- K955137 — IM C-MENT ACETABULAR CAP · Implant Ideas, LLC · Oct 10, 1996
- K023786 — DEPUY PINNACLE METAL-ON-METAL ACETABULAR CUP LINER · DePuy Orthopaedics, Inc. · Dec 10, 2002
- K022094 — PAR 5 ACETABULAR COMPONENT WITH & WITHOUT HYDROXYAPATITE COATING · Biomet, Inc. · Jul 25, 2002
- K030861 — HA PMI FLANGED ACETABULAR COMPONENT · Biomet, Inc. · Jun 12, 2003
