(83 days)
The MS-30 Femoral Stem is intended for cemented use in treatment of the following:
- Advanced wear of the joint due to degenerative, posttraumatic or rheumatic diseases.
- Fractures or vascular necroses.
- Status following earlier operations, such as joint reconstruction (osteotomy), arthrodesis, hemiarthroplasty of total hip prosthesis (THP).
The MS-30 is a highly polished metallic femoral component manufactured from forged stainless steel alloy (Protasul S30, ISO 5832-9). It is available in six sizes. The stem features a three dimensional conical wedge shape with rounded edges to aid in rotational stability, self centering in the femoral canal, and creation of a favorable cement mantle. The proximal aspect of the stem has a male 12/14 type morse taper for attachment of a Sulzer Orthopedics metallic or ceramic femoral The most distal aspect of the stem has a small pilot hole for attachment of a distal head. centralizer. The stem is intended for cemented use only.
The MS-30 also features an optional distal centralizer which is manufactured from PMMA (ISO 5833-1) with a wrought CoCr alloy locating pin (Protasul 10, ISO 5832-6). The pin provides for slip fit connection to the distal stem. The centralizer is conically shaped with a small proximal tab that prevents rotation about the stem upon insertion into the canal.
This document is a 510(k) Summary for the Sulzer Orthopedics MS-30 Femoral Stem, a medical device for hip replacement, and does not contain the type of information requested regarding acceptance criteria and a study proving device performance.
The provided text focuses on:
- Product Description: Materials, design, and sizes of the femoral stem and optional distal centralizer.
- Specific Diagnostic Indications: Conditions for which the device is intended.
- Substantial Equivalence: Comparison to other commercially available devices and a general statement that "Testing/analysis indicated that the device would survive physiologic loading."
It does not provide:
- A table of acceptance criteria and reported device performance.
- Sample sizes or data provenance for a test set.
- Details on experts for ground truth establishment.
- Adjudication methods.
- Information on multi-reader multi-case (MRMC) comparative effectiveness studies.
- Results from standalone performance studies.
- The type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
This document is primarily for regulatory submission to demonstrate substantial equivalence to previously cleared devices, rather than a detailed performance study report.
§ 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.