(157 days)
Joint replacement is indicated for patients suffering from disability due to:
· Noninflammatory degenerative joint disease
including osteoarthritis and avascular necrosis of the natural femoral head
· Rheumatoid arthritis
· Correction of functional deformity
- Femoral fracture
This device may also be indicated in the salvage of previously failed surgical attempts.
. The constrained acetabular component is indicated for primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability and for who all other options to constrained acetabular components have been considered.
This stem is to be press-fit. This stem is intended for cementless use.
The purpose of this application is to include a new line extension to the current Linear™ Porous Coated Hip Stem. The TaperFill Femoral Hip stem is designed with a reduced neck, shorter length, and increased proximal width as compared to the predicate Linear™ Hip Stem (K974294). The TaperFill™ stem has an equivalent or larger cross section area in all locations.
The TaperFill™ Femoral Hip Stem is fabricated from wrought/forged Ti-6A1-4V that conforms to ASTM F136. The outside surface of the stem is porous coated with commercially pure titanium (ASTM F67 grade 2) to provide a porous surface.
There are no changes to materials, sterilization, packaging, or method of manufacture. The major dimensional changes are isolated below the calcar line, with TaperFill incorporating a larger anteriorposterior cross-sectional width and a reduced overall stem length. The critically stressed neck regions of the stem and the modular taper that mates with the existing modular heads are identical to the cleared Linear™ Hip Stem (K974294).
The provided information is for K130099, the TaperFill™ Femoral Hip Stem. This is a medical device application for a hip stem, and not a software or AI device. Therefore, the questions regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment, which are typically relevant for AI/ML-based medical devices, are not applicable in this context.
Summary of the provided information about K130099:
- Device Name: TaperFill™ Femoral Hip Stem
- Manufacturer: Encore Medical, L.P. (DJO Surgical)
- Classification: Class II
- Product Codes: LPH, LZO, KWZ (all related to hip joint prostheses)
- Description: A line extension to the Linear™ Porous Coated Hip Stem, featuring a reduced neck, shorter length, and increased proximal width. It's made from Ti-6A1-4V with a porous coating of commercially pure titanium.
- Indications for Use: Joint replacement for noninflammatory degenerative joint disease (osteoarthritis, avascular necrosis), rheumatoid arthritis, correction of functional deformity, femoral fracture, and salvage of failed surgical attempts. It is intended for cementless, press-fit use.
- Predicate Devices: Linear™ Porous Coated Hip Stem (K974294), P2 Coating on Linear Stem (K081679), P2 Coating on Linear Hip Stem Size 8 (K120241).
- Comparable Features: Same indications, materials, sterilization, packaging, and intended use as predicate devices.
- Non-Clinical Testing: Dimensional analysis, range of motion analysis.
- Clinical Testing: None provided.
Since this is a traditional medical device (hip stem) and not an AI/ML device, the questions about acceptance criteria related to algorithmic performance, study design with test sets, training sets, and expert evaluations are not applicable. The device's "performance" in this context would be assessed through non-clinical testing (dimensional, range of motion) and its substantial equivalence to predicate devices, rather than through accuracy, sensitivity, or specificity metrics characteristic of AI evaluation.
§ 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.