OIS · Calcium Salt Bone Void Filler, Drillable, Non-Screw Augmentation
Orthopedic · 21 CFR 888.3045 · Class 2
Overview
| Product Code | OIS |
|---|---|
| Device Name | Calcium Salt Bone Void Filler, Drillable, Non-Screw Augmentation |
| Regulation | 21 CFR 888.3045 |
| Device Class | Class 2 |
| Review Panel | Orthopedic |
| Implant | Yes |
Identification
A resorbable calcium salt bone void filler device is a resorbable implant intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.
Classification Rationale
Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA.” See § 888.1(e) of this chapter for the availability of this guidance.
Special Controls
*Classification.* Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA.” See § 888.1(e) of this chapter for the availability of this guidance.
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K073303 | NORIAN DRILLABLE | Synthes (Usa) | Jul 2, 2008 | SESU |
| P860005 | PRO OSTEON IMPLANT 500 HYDROXYAPATITE BONE VOID FILLER | Interpore Intl. | Oct 29, 1992 | APRL |
Top Applicants
- Interpore Intl. — 1 clearance
- Synthes (Usa) — 1 clearance
