← Product Code [LPH](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/LPH) · K961625 # QUATROLOC FEMORAL COMPONENT & HEAD (K961625) _Whiteside Biomechanics, Inc. · LPH · Sep 10, 1996 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/LPH/K961625 ## Device Facts - **Applicant:** Whiteside Biomechanics, Inc. - **Product Code:** [LPH](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/LPH.md) - **Decision Date:** Sep 10, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3358 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Intended Use This device is intended to be used for: 1. noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis, 2. rheumatoid arthritis, 3. correction of functional deformity, 4. revision procedures where other treatments or devices have failed, and 5. treatment of non-unions, femoral neck and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques. ## Device Story Modular femoral hip prosthesis; wrought titanium 6Al-4V stem; rectangular cross-section; tapered proximal end; porous-coated with commercially pure titanium beads for uncemented fixation; distal stem smooth A-P taper with M-L step-cut. Intended for use with conventional cobalt-chrome modular femoral heads and acetabular implants. Surgeon-implanted in clinical setting to restore joint function in patients with degenerative disease, arthritis, or fractures. Provides stable femoral fixation via osseointegration of porous coating. ## Clinical Evidence Bench testing only. ## Technological Characteristics Materials: Wrought titanium 6Al-4V (ASTM F1472) stem; commercially pure titanium beads (-45+60Mesh) for porous coating (3 layers, 0.030" thickness). Design: Rectangular cross-section, tapered proximal end, distal smooth A-P taper, M-L step-cut. Sterilization: 100% ethylene oxide and nitrogen per AAMI guidelines. ## Regulatory 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. ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} SEP 10 1996 K961625 510(k) SUMMARY ## Device: Classification Name: Prosthesis Hip, Semi-constrained, Metal / Polymer, Porous Uncemented Classification No.: 87LPH Common / Usual Name: Modular femoral component and head Proprietary Name: Quatroloc Femoral Component and Head ## Manufacturer Identification: Whiteside Biomechanics, Inc. 12634 Olive Blvd. Creve Coeur, MO 63141 Establishment Registration Number: 1932213 ## Device Description: The implant will consist of a solid, rectangularly cross-sectioned wrought titanium 6Al- 4V (ASTM 1472) stem with a tapered proximal end intended to seat a conventional cobalt-chrome modular spheric articular interface. The device is intended to articulate with a conventional acetabular implant of the surgeon's choice. The distal will be a smooth taper A-P and will be step-cut with parallel sides M-L. The proximal stem will be porous coated with commercially pure titanium beads on all surfaces excluding the articular interface trunnion. ## Intended Use: This device is intended to be used for: 1. noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis, 2. rheumatoid arthritis, 3. correction of functional deformity, 4. revision procedures where other treatments or devices have failed, and 5. treatment of non-unions, femoral neck and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques. ## Additional Information: This femoral component is made of wrought titanium 6Al-4V (ASTM F1472). The proximal portion of the stem will be porous coated on all surfaces, excluding the ball trunnion. The porous coating will consist of 3 layers (0.030" total thickness) of commercially pure titanium beads (-45+60Mesh). The device is to be sterilized with 100% ethylene oxide and nitrogen in accordance with AAMI guidelines for sterilization. --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/LPH/K961625](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/LPH/K961625) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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