Chrysalis Intelligence · Product Codes · NDN

NDN · Cement, Bone, Vertebroplasty

Orthopedic · 16 clearances · 13 unique sponsors

Device class
Class II
Regulation 888.3027
Total clearances
16
2020-03-05 → 2026-01-28
Last 12 months
1
Unique sponsors
13
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
Xelite Biomed , Ltd. 3 1 2026-01-28
Stryker Instruments 2 0 2022-12-20
Tecres S.P.A. 1 0 2022-04-18
Hyprevention Sas 1 0 2020-03-05
Slk Ortho, LLC 1 0 2023-03-03
Depuy Spine, Inc. 1 0 2020-08-31
Ningbo Hicren Biotechnology Co., Ltd. 1 0 2024-02-29
Hyprevention 1 0 2024-02-09
Amber Implants 1 0 2025-05-30
Joline GmbH & Co. KG 1 0 2020-05-27
GS Medical Co., Ltd. 1 0 2021-10-28
Biopsybell S.R.L. 1 0 2023-10-30
Stryker Corporation 1 0 2020-10-20
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.

CodeTypeDescriptionConfidenceRationale
22520 CPT Medium Percutaneous vertebroplasty (including cement injection) typically includes material; this represents the bone cement component
C1713 HCPCS Anchor/screw for opposing bone-to-bone or soft tissue-to-bone (implantable) ✓ CMS-verified description Medium HCPCS code for bone void filler or cement
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2026-01-28 K251896 Xelite Biomed , Ltd. XeliteMed SuperM-Fix Spinal Bone Cement
2025-05-30 K250637 Amber Implants VCFix Spinal System
2025-04-11 K243537 Xelite Biomed , Ltd. XeliteMed VertehighFix High Viscosity Spinal Bone Cement System
2024-09-18 K241775 Xelite Biomed , Ltd. XeliteMed VertehighFix High Viscosity Spinal Bone Cement
2024-02-29 K232842 Ningbo Hicren Biotechnology Co., Ltd. Balloon Inflation System
2024-02-09 K240084 Hyprevention V-STRUT® Vertebral Implant
2023-10-30 K231340 Biopsybell S.R.L. Renova Spine Balloon Catheter
2023-03-03 K221697 Slk Ortho, LLC INJECTION PIN (KIP(02031-02061) (03031-03061))
2022-12-20 K223294 Stryker Instruments SpineJack® Expansion Kit
2022-04-18 K220131 Tecres S.P.A. KYPHON VuE Bone Cement
2021-10-28 K211797 GS Medical Co., Ltd. TRACKER Plus Kyphoplasty System
2021-06-25 K211238 Stryker Instruments SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex HV Radiopaque Bone Cement
2020-10-20 K202393 Stryker Corporation SpineJack Expansion Kit
2020-08-31 K201831 Depuy Spine, Inc. CONFIDENCE Spinal Cement System
2020-05-27 K192449 Joline GmbH & Co. KG Joline Kyphoplasty System Allevo
2020-03-05 K191709 Hyprevention Sas V-STRUT Vertebral Implant