LOD · Bone Cement · Chrysalis Intelligence

Device class

Class II

Regulation 888.3027

Total clearances

2020-03-19 → 2026-04-15

Last 12 months

Unique sponsors

Classification details

Medical specialty

Orthopedic

Review panel

Regulation number

888.3027

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
Heraeus Medical GmbH	4	0	2024-12-05
Osartis GmbH	3	0	2021-05-18
G21, S.R.L.	2	0	2020-03-19
Osteoremedies, LLC	2	0	2025-04-02
Tecres S.P.A.	1	0	2023-01-09
Biomet France	1	1	2026-04-15
Biomecanica Industria E Comerciode Produtos Ortopedicos Ltda	1	0	2022-05-31
Ormed Grup Medikal Turizm Saglik Hizmetleri Sanayi VE	1	0	2022-05-19

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.

Code	Type	Description	Confidence	Rationale
A4611	HCPCS	Battery, heavy duty; replacement for patient owned ventilator ✓ CMS-verified description	High	Bone cement supply for orthopedic fixation
20999	CPT	—	Medium	Unlisted procedure musculoskeletal; bone cement application bundled

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-04-15	K254107	Biomet France	Refobacin Bone Cement R (110034355)
2025-04-02	K250760	Osteoremedies, LLC	SPECTRUM GV Bone Cement
2024-12-05	K241674	Heraeus Medical GmbH	OSTEOPAL® V
2023-12-20	K231556	Osteoremedies, LLC	SPECTRUM® GV Bone Cement
2023-01-09	K211163	Tecres S.P.A.	Bone Cement Genta, Bone Cement HV, Bone Cement LV
2022-05-31	K212729	Biomecanica Industria E Comerciode Produtos Ortopedicos Ltda	Bone Cement-Normal Viscosity
2022-05-19	K211869	Ormed Grup Medikal Turizm Saglik Hizmetleri Sanayi VE	OGM 1 Polymethylmethacrylate (PMMA) bone cement, OGM 1A Polymethylmethacrylate (PMMA) bone cement
2022-02-02	K213812	Heraeus Medical GmbH	PALACOS MV pro
2021-07-09	K210607	Heraeus Medical GmbH	PALACOS R pro, PALACOS R+G pro, PALACOS MV+G pro
2021-05-18	K202458	Osartis GmbH	BonOs Inject, Pedicle screw kits, Cement pusher
2021-03-19	K210125	Osartis GmbH	BonOs HV Genta, BonOs MV Genta, BonOs LV Genta
2021-03-19	K210120	Osartis GmbH	BonOs HV, BonOs MV, BonOs LV
2020-11-23	K202475	Heraeus Medical GmbH	PALACOS R, PALACOS R pro, PALACOS R+G, PALACOS R+G pro, PALACOS MV+G
2020-03-19	K193061	G21, S.R.L.	G3 40 Radiopaque Bone Cement
2020-03-19	K193059	G21, S.R.L.	G1 40 Radiopaque Bone Cement