(30 days)
The device is indicated for use in hip arthroplasty in skeletally mature patients with the following conditions:
- A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia.
- Avascular necrosis of the femoral head.
- Acute traumatic fracture of the femoral head or neck.
- Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement or total hip replacement.
- Certain cases of ankylosis.
Conformity stem is for cementless use only.
The "United" Conformity Stem cementless type (K183312) is designed for cementless use in hip arthroplasty. The Conformity Stem cementless type is a proximal trapezoid and distal quadrangular stem with 12/14 neck taper, 135° and 125° neck angle. It is manufactured from Ti-6Al-4V alloy, which conforms to ASTM F136-13 and the distal part of each femoral stem is coated with hydroxyapatite (HA) (ASTM F1185-03) to provide biological fixation. The "United" Conformity Stem cementless is available in various sizes with collarless and collared types to accommodate various hip surgical requirements.
For the subject device, it's an extension line of the 510(K) cleared device Conformity Stem cementless type (K183312), which introduces two new variations: (1) Conformity stem, coxa vara, 125° STD, collared, #1-7; and (2) Conformity stem, short neck, #4-7. The indications, design rationales, materials, major manufacturing process, and sterilization method of the subject devices are identical to the 510(k) cleared Conformity Stem, cementless (K183312).
Conformity Stem can collocate with "United" metallic femoral heads (K994078, K022520, K111546, K122504, K152439, K162957, K221675) or ceramic femoral heads (K103497, K112463, K122185).
- Conformity stem, coxa vara, 125° STD, collared
Conformity stem, coxa vara, 125° STD, collared is a new coxa vara type variation of 510(k) cleared Conformity stem, coxa vara (1110-52XX, K183312). The same as this 510(k) cleared device, it's also made of Ti-6Al-4V alloy (ASTM F136), and the distal part is coated with hydroxyapatite(HA) (ASTM F1185). In addition, the subject device is also a collared stem with a 125° neck angle. The only difference is the offset design. The subject device is standard offset, while the 510(k) cleared coxa vara collared stem (110-52XX) is high offset - Conformity Stem, short neck, #4-7
Conformity stem, short neck, #4-7 is an extension in terms of sizes to 510 (k) cleared device Conformity stem, short neck, #1-3 (K183312). The design, material, coating thickness, geometrical characteristics, neck angle (135°), and neck length (28.5mm) design are identical to 510 (k) cleared device Conformity Stem, short neck, #1-3 (K183312). The only different is the stem length sizes.
This is an FDA 510(k) clearance letter for a medical device called "Conformity Stem Extension Line." This document does not describe acceptance criteria for an AI/ML device or a study proving that an AI/ML device meets those criteria. Instead, it describes mechanical analyses performed on a physical orthopedic implant.
Therefore, I cannot extract the requested information regarding acceptance criteria and study details for an AI/ML device from this document. The document pertains to a hip joint prosthesis, which is a physical implant, not a software device.
§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.