NDN · Cement, Bone, Vertebroplasty
Orthopedic · 21 CFR 888.3027 · Class 2
Overview
| Product Code | NDN |
|---|---|
| Device Name | Cement, Bone, Vertebroplasty |
| Regulation | 21 CFR 888.3027 |
| Device Class | Class 2 |
| Review Panel | Orthopedic |
| Implant | Yes |
Identification
Polymethylmethacrylate (PMMA) bone cement is a device intended to be implanted that is made from methylmethacrylate, polymethylmethacrylate, esters of methacrylic acid, or copolymers containing polymethylmethacrylate and polystyrene. The device is intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone.
Classification Rationale
Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement.”
Special Controls
*Classification.* Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement.”
Recent Cleared Devices (20 of 108)
Showing 20 most recent of 108 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K251896 | XeliteMed SuperM-Fix Spinal Bone Cement | Xelite Biomed , Ltd. | Jan 28, 2026 | SESE |
| K250637 | VCFix Spinal System | Amber Implants | May 30, 2025 | SESE |
| K243537 | XeliteMed VertehighFix High Viscosity Spinal Bone Cement System | Xelite Biomed , Ltd. | Apr 11, 2025 | SESE |
| K241775 | XeliteMed VertehighFix High Viscosity Spinal Bone Cement | Xelite Biomed , Ltd. | Sep 18, 2024 | SESE |
| K232842 | Balloon Inflation System | Ningbo Hicren Biotechnology Co., Ltd. | Feb 29, 2024 | SESE |
| K240084 | V-STRUT® Vertebral Implant | Hyprevention | Feb 9, 2024 | SESE |
| K231340 | Renova Spine Balloon Catheter | Biopsybell S.R.L. | Oct 30, 2023 | SESE |
| K221697 | INJECTION PIN (KIP(02031-02061) (03031-03061)) | Slk Ortho, LLC | Mar 3, 2023 | SESE |
| K223294 | SpineJack® Expansion Kit | Stryker Instruments | Dec 20, 2022 | SESE |
| K220131 | KYPHON VuE Bone Cement | Tecres S.P.A. | Apr 18, 2022 | SESE |
| K211797 | TRACKER Plus Kyphoplasty System | GS Medical Co., Ltd. | Oct 28, 2021 | SESE |
| K211238 | SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex HV Radiopaque Bone Cement | Stryker Instruments | Jun 25, 2021 | SESE |
| K202393 | SpineJack Expansion Kit | Stryker Corporation | Oct 20, 2020 | SESE |
| K201831 | CONFIDENCE Spinal Cement System | Depuy Spine, Inc. | Aug 31, 2020 | SESE |
| K192449 | Joline Kyphoplasty System Allevo | Joline GmbH & Co. KG | May 27, 2020 | SESE |
| K191709 | V-STRUT Vertebral Implant | Hyprevention Sas | Mar 5, 2020 | SESE |
| K192335 | TRACKER Kyphoplasty System | GS Medical Co., Ltd. | Dec 4, 2019 | SESE |
| K192403 | VK100 Percutaneous Vertebral Augmentation System | Bonwrx, Ltd. | Nov 8, 2019 | SESE |
| K181262 | SpineJack Expansion Kit | Vexim SA | Aug 30, 2018 | SESE |
| K172871 | SpineKure Kyphoplasty System | Hanchang Co., Ltd. | May 29, 2018 | SESE |
Top Applicants
- Arthrocare Corp. — 6 clearances
- Stryker Corporation — 5 clearances
- Tecres S.P.A. — 5 clearances
- Dfine, Inc. — 4 clearances
- Disc-O-Tech Medical Technologies, Ltd. — 4 clearances
