BIOMET ORTHOPAEDIC SALVAGE SYSTEM (OSS)

• K Number: K141331
• Device Name: BIOMET ORTHOPAEDIC SALVAGE SYSTEM (OSS)
• Manufacturer: BIOMET, INC.
• Date Cleared: 2014-10-27 ( 159 days)
• Product Code: JDI , KRO , LPH
• Regulation Number: 888.3350
• Type: Traditional
• Panel: OR
• Reference & Predicate Devices: K122770 , K072336 , K002757 , K052685 , K123501 , K110940
• Predicate For: K142814

Intended Use

OSS INDICATIONS

1. Painful and disabled joint resulting from avascular necrosis, osteoarthritis, rheumatoid arthritis, or traumatic arthritis.
2. Correction of varus, valgus, or posttraumatic deformity.
3. Correction or revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement.
4. Ligament deficiencies.
5. Tumor resections.
6. Treatment of non-unions, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques. *
7. Revision of previously failed total joint arthroplasty.
8. Trauma.

These devices are to be used with bone cement unless composed of OsseoTi (titanium alloy, not licensed in Canada) or a proximal femur is indicated for use (USA).

Biomet OSS Reduced size (RS) components offers a variety of component options for treatment in small adults and adolescents (12-21 years) that require proximal femoral, distal femoral, total femur, or proximal tibial replacement as well as, resurfacing components for the proximal tibia and distal femur (USA).

• Not applicable to Regenerex Ultra Porous Construct titanium knee augment usage (not licensed in Canada), or any other knee component.

COMPRESS INDICATIONS
The Compress Segmental Femoral Replacement System is indicated for:

1. Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement.
2. Tumor resections.
3. Revision of previously failed total joint arthroplasty.
4. Trauma.

The Compress Segmental Femoral Replacement System components are intended for uncemented use.

When components of the Orthopaedic Salvage System are used with Biomet's Compress Segmental Femoral Replacement System, the user should refer to the package insert contained with the Compress components for full prescription information.

Device Description

The new devices included in this submission are additional components to Biomet's Orthopaedic Salvage System (OSS) that offer surgeons additional prostheses options to be used in limb salvage reconstruction. The new devices include distal femoral component, proximal femoral component, proximal tibial sleeve, diaphyseal segment, splined stem, diaphyseal augment and metaphyseal augment.

AI/ML Overview

I am sorry, but the provided text does not contain the level of detail required to answer your request regarding acceptance criteria and study information for a medical device. The document is a 510(k) summary for a medical device (Biomet Orthopaedic Salvage System (OSS) Line Extension) indicating substantial equivalence to predicate devices, but it does not include:

1. A table of acceptance criteria and reported device performance: The document lists "Device Fatigue Testing", "Device Static Disassociation Testing", "Tensile Properties Testing", and "Material Characterization for OsseoTi" as performed tests, but does not provide specific acceptance criteria or the numerical results of these tests.
2. Sample sizes used for the test set and data provenance: No information on sample sizes (N) for any of the non-clinical tests is given.
3. Number of experts used to establish ground truth and their qualifications: This is not applicable as no clinical study for ground truth establishment is mentioned.
4. Adjudication method: Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: The document explicitly states "No clinical testing was necessary for a determination of substantial equivalence." and "Clinical Performance Data/Information: N/A". Therefore, no MRMC study was conducted.
6. Standalone performance (algorithm only without human-in-the-loop performance): This is not applicable as the device is a physical orthopedic implant system, not a software algorithm.
7. Type of ground truth used: Not applicable as no clinical study requiring ground truth was conducted.
8. Sample size for the training set: Not applicable as this relates to AI/machine learning models, and the device is a physical implant.
9. How the ground truth for the training set was established: Not applicable for the same reason as above.

The document primarily focuses on demonstrating substantial equivalence to existing predicate devices based on non-clinical performance testing and material characterization, without the need for new clinical studies to establish safety and effectiveness for a novel performance claim.

Regulation Number and Section

§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.

(a)
Identification. A hip joint metal/polymer semi-constrained cemented 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 includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.