21 CFR 888.3045 — Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)
Orthopedic (OR) · Part 888 Subpart D—Prosthetic Devices · § 888.3045
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| MBP | Filler, Bone Void, Osteoinduction (W/O Human Growth Factor) | 2 | 31 | Implant |
| MQV | Filler, Bone Void, Calcium Compound | 2 | 489 | Implant |
| OIS | Calcium Salt Bone Void Filler, Drillable, Non-Screw Augmentation | 2 | 2 | Implant |
Special Controls
MBP — Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)
*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.
eCFR
MBP — Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)
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.
Ecfr Llm
MQV — Filler, Bone Void, Calcium Compound
*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.
eCFR
OIS — Calcium Salt Bone Void Filler, Drillable, Non-Screw Augmentation
*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.
eCFR
