Cleared Traditional

K242865 - Synicem Hip Spacer (FDA 510(k) Clearance)

Also includes:
Synicem Knee Spacer Synicem Shoulder Spacer

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K242865 · Biocomposites, Ltd. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2025
Decision
265d
Days
Class 2
Risk

K242865 is an FDA 510(k) clearance for the Synicem Hip Spacer. Classified as Prosthesis, Hip, Hemi-, Femoral, Metal (product code KWL), Class II - Special Controls.

Submitted by Biocomposites, Ltd. (Keele, GB). The FDA issued a Cleared decision on June 12, 2025 after a review of 265 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3360 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Biocomposites, Ltd. devices

Submission Details

510(k) Number K242865 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 2024
Decision Date June 12, 2025
Days to Decision 265 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
143d slower than avg
Panel avg: 122d · This submission: 265d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KWL Prosthesis, Hip, Hemi-, Femoral, Metal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3360
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - KWL Prosthesis, Hip, Hemi-, Femoral, Metal

All 105
Devices cleared under the same product code (KWL) and FDA review panel - the closest regulatory comparables to K242865.
OsteoRemedies Hip Spacer System
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InterSpace GV Hip Spacer
K252326 · Tecres S.P.A. · Aug 2025
COPAL® exchange G hip spacer
K234028 · Heraeus Medical GmbH · Feb 2024
UHR Bipolar Implants, Restoration GAP II Implants
K222632 · Howmedica Osteonics Corp., Dba Stryker Orthopaedics · Oct 2022