ENCOMPASS HIP STEM, TRI-PLUS ACETABULAR SHELL, TRI-PLUS DCM LINER

• K Number: K042565
• Device Name: ENCOMPASS HIP STEM, TRI-PLUS ACETABULAR SHELL, TRI-PLUS DCM LINER
• Manufacturer: ORTHO DEVELOPMENT CORP.
• Date Cleared: 2005-04-11 ( 202 days)
• Product Code: LPH , MBL
• Regulation Number: 888.3358
• Type: Traditional
• Panel: OR
• Reference & Predicate Devices: N/A

Intended Use

The device is Intended for use in total hij› arthroplasty. The device is intended for uncemented, press-fit use only.

• 1. Notably impaired hip joint due to usteoarthritis, rheumatoid arthritis and/or post traumatic arthritis.
• 2. Previously failed surgery.
• 3. Proximal femoral neck fractures or dislocation.
• 4. Idiopathic avascular necrosis of the femoral head.
• 5. Non-union of proximal femoral ne :k fractures.
• 6. Treatment of fractures that are un nanageable using other forms of therapy.
• 7. Benign or malignant bone tumors congenital dysplasia or other structural abnormalities where sufficient bo re stock exists to properly seat the prosthesis.

Device Description

Encompass™ Plasma Sprayed, Press-fit Hip System: Encompass™ Hip Stem, Tri-plus™ Acetabular Shell, Tri-plus™ DCM Liner

AI/ML Overview

The provided document is a 510(k) clearance letter from the FDA for the Encompass™ Plasma Sprayed, Press-fit Hip System. It confirms that the device is substantially equivalent to a legally marketed predicate device.

However, this document does not contain any information regarding acceptance criteria or a study that proves the device meets specific performance criteria as typically found in a clinical or performance study report. It is a regulatory clearance, not a performance evaluation.

Therefore, I cannot extract the requested information. The document primarily focuses on regulatory classification, indications for use, and confirmation of substantial equivalence to a predicate device.

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.