Chrysalis Intelligence · Product Codes · MBB

MBB · Bone Cement, Antibiotic

Orthopedic · 8 clearances · 4 unique sponsors

Device class
Class II
Regulation 888.3027
Total clearances
8
2020-08-13 → 2025-09-15
Last 12 months
1
Unique sponsors
4
Medical specialty
Orthopedic
Review panel
OR
Regulation number
888.3027
Implant
Y
Life-sustain / support
N
GMP exempt
N
Third-party review
N
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
G21, S.R.L. 3 1 2025-09-15
Biomet, Inc. 3 0 2022-12-28
Teknimed Sas 1 0 2024-12-18
Osartis GmbH 1 0 2024-11-20
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
20974 CPT High CPT code for vertebral body tamps, including insertion of bone cement for stabilization when performed
99070 CPT Medium CPT code for supplies and materials; antibiotic bone cement may be billed as supply when used separately
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2025-09-15 K252443 G21, S.R.L. SpaceFix Shoulder Spacer
2024-12-18 K242216 Teknimed Sas GENTAFIX® (1, 3, 3MV)
2024-11-20 K240856 Osartis GmbH Hip Spacer Molds; Knee Spacer Molds; Shoulder Spacer Molds
2022-12-28 K222760 Biomet, Inc. StageOne™ Select Hip Cement Spacer Molds
2022-09-15 K221968 Biomet, Inc. StageOne™ Shoulder Cement Spacer Molds
2022-09-02 K213287 Biomet, Inc. StageOne Knee Cement Spacer Molds
2021-02-17 K202338 G21, S.R.L. SpaceFlex Shoulder
2020-08-13 K201960 G21, S.R.L. SpaceFlex Knee - 80mm Size