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
0
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 0 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