PML · Bone Cement, Posterior Screw Augmentation

Device class

Class II

Regulation 888.3027

Total clearances

2020-03-31 → 2026-06-15

Last 12 months

Unique sponsors

Definition

What is Bone Cement, Posterior Screw Augmentation

The device is intended to augment the fixation of screws in a posterior spinal system construct.

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
Neo Medical SA	2	0	2022-08-26
Icotec AG	2	0	2023-01-09
Medacta International S.A.	1	0	2024-06-12
Spine Wave, Inc.	1	1	2026-06-15
Alphatec Spine, Inc.	1	0	2022-12-20
Astura Medical	1	1	2026-01-22
Medtronic	1	0	2020-08-19
Spineart	1	0	2023-06-23
Stryker Corporation	1	0	2020-03-31
Ulrich Medical USA	1	0	2023-10-20

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.

Code	Type	Description	Confidence	Rationale
22853	CPT	—	High	Percutaneous vertebroplasty, posterior screw augmentation with cement injection
22842	CPT	—	Medium	Posterior instrumented fusion; bone cement augmentation of screw fixation

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-06-15	K260286	Spine Wave, Inc.	Dynamo Spinal Cement; Salvo® Spine System
2026-01-22	K252885	Astura Medical	OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System
2024-06-12	K241034	Medacta International S.A.	Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw System
2023-10-20	K231809	Ulrich Medical USA	Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS Posterior Spinal Fixation System with G21 V-STEADY Bone Cement
2023-06-23	K230774	Spineart	PERLA® TL System; TEKTONA® HV US Bone Cement
2023-01-09	K222789	Icotec AG	VADER® Pedicle System, G21 Cement
2022-12-20	K221926	Alphatec Spine, Inc.	Invictus® Bone Cement, Invictus Spinal Fixation System
2022-08-26	K222256	Neo Medical SA	BonOs® Inject Bone Cement; NEO Pedicle Screw System
2021-10-28	K212489	Neo Medical SA	BonOs Inject Bone Cement; NEO Pedicle Screw System
2020-10-13	K200596	Icotec AG	G21 Cement, VADER® Pedicle System
2020-08-19	K201362	Medtronic	CD Horizon Fenestrated Screw Set, CD Horizon Spinal System, Kyphon HV-R Bone Cement
2020-03-31	K192818	Stryker Corporation	Vertaplex HV High Viscosity Radiopaque Bone Cement; ES2 Augmentable Spinal System