Chrysalis Intelligence · Product Codes · KWL

KWL · Unclassified

8 clearances · 6 unique sponsors

Device class
Regulation —
Total clearances
8
2020-01-10 → 2026-07-24
Last 12 months
3
Unique sponsors
6
Medical specialty
Review panel
Regulation number
Implant
Life-sustain / support
GMP exempt
Third-party review
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
Osteoremedies, LLC 3 2 2026-07-24
Tecres S.P.A. 1 0 2025-08-06
Depuy Ireland UC 1 1 2026-05-15
Heraeus Medical GmbH 1 0 2024-02-15
Biocomposites, Ltd. 1 0 2025-06-12
Howmedica Osteonics Corp., Dba Stryker Orthopaedics 1 0 2022-10-21
Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

CodeTypeDescriptionConfidenceRationale
27125 CPT High Standard CPT for hip prosthesis hemi-implantation, femoral
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2026-07-24 K262290 Osteoremedies, LLC REMEDY POLY+PLUS SNAP FIT Acetabular Cup
2026-05-15 K260536 Depuy Ireland UC Prostalac Hip System, SmartSet V+G Dual Antibiotic Bone Cement
2025-12-23 K253675 Osteoremedies, LLC OsteoRemedies Hip Spacer System
2025-08-06 K252326 Tecres S.P.A. InterSpace GV Hip Spacer
2025-06-12 K242865 Biocomposites, Ltd. Synicem Hip Spacer; Synicem Knee Spacer; Synicem Shoulder Spacer
2024-02-15 K234028 Heraeus Medical GmbH COPAL® exchange G hip spacer; COPAL® G+V
2022-10-21 K222632 Howmedica Osteonics Corp., Dba Stryker Orthopaedics UHR Bipolar Implants, Restoration GAP II Implants
2020-01-10 K192995 Osteoremedies, LLC OsteoRemedies Hip Spacer System