# K242865: Synicem Hip Spacer; Synicem Knee Spacer; Synicem Shoulder Spacer

- Pathway: 510(k) (Traditional)
- Applicant: Biocomposites, Ltd.
- Decided: Jun 12, 2025 after 265 days
- Product code: KWL (Prosthesis, Hip, Hemi-, Femoral, Metal)
- Device class: 2
- Regulation: 21 CFR 888.3360
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Spacer-G, Temporary Hip Spacer with Gentamicin: named in the summary without a submission number
- (no number) Spacer-K, Temporary Knee Spacer with Gentamicin: named in the summary without a submission number
- (no number) Spacer-S, Temporary Shoulder Spacer with Gentamicin: named in the summary without a submission number

## Indications for use
The Hip Spacer with gentamicin preserves the joint space and the length of the affected limb, which results in the maintenance of the entire abductor and stabilizer apparatus of the hip. Its use is indicated for a limited period, in patients who require a two-stage Revision Arthroplasty. A systemic antibiotic therapy should also be prescribed while the spacer remains implanted. The Hip Spacer is implanted after the removal of the infected implant, as a regular Hemiarthroplasty. The spacer is inserted into the femoral canal, and a handmade ring of PMMA bone cement with antibiotic may be added to the base of the spacer’s neck in order to increase stability. The spacer is kept “in place” until it is replaced by the final prosthesis according to medical criteria. The Hip Spacer must not remain implanted for more than 6 months. Once this period has elapsed, it must be explanted and a permanent device implanted or another appropriate treatment performed. The Knee Spacer with gentamicin maintains the articular space, the length of the affected limb, and the ligament apparatus of the knee. Its use is indicated for a limited period, in patients who require a Two stage Revision Arthroplasty. A systemic antibiotic therapy should also be prescribed while the spacer remains implanted. The Knee Spacer is placed like a regular arthroplasty, after the removal of the original implant. This knee spacer consists of two independent parts: a tibial plate and a femoral component. The first has a flat base where the femoral component articulates. It is recommended that both components be adapted to the bone by means of a small amount of bone cement with antibiotic. The Knee Spacer must not remain implanted more than 6 months. Once this period has elapsed, it must be explanted and a permanent device implanted or another appropriate treatment performed. The Shoulder Spacer with gentamicin preserves joint space and length of the affected limb, resulting in maintenance of the entire shoulder muscle and stabilizer complex. Its use is indicated for a limited period, in patients who require a Two-stage Revision Arthroplasty. A systemic antibiotic therapy should also be prescribed while the spacer remains implanted. The Shoulder Spacer is placed as a hemiarthroplasty after the original implant has been removed. The spacer is inserted into the humeral canal and a ring of bone cement with antibiotic can be added to the base of the neck of the spacer for added stability. The Shoulder Spacer should not remain in place for more than 6 months. Once this period has elapsed, it must be explanted and a permanent device implanted or another appropriate treatment performed.

Source page: https://510kreport.com/device/K242865
Methodology: https://510kreport.com/methodology