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BIOSORB BIO1 Macroporous

by S.B.M

BIOSORB BIO1 Macroporous (P822893232) is a Class II device made by S.B.M, cleared under FDA 510(k) K021963 on 28 Jan 2003 and listed in FDA GUDID since 24 Sep 2015 (UDI-DI 03760154000710), active as of 23 Oct 2026. One FDA recall is linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

510(k) K021963

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number03760154000710 UDI-DI Date24 Sep 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK021963 Date28 Jan 2003DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K021963 decided 28 Jan 2003 Active
  • FDA GUDID UDI-DI 03760154000710 listed 24 Sep 2015 Listed

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-1718-2025 FDA Class II initiated 7 Apr 2025

    Vials of implant bone granules may contain less product then specified on labeling.

Timeline

3 dated events

  1. Cleared FDA 510(k) K021963
  2. Listed FDA GUDID 03760154000710
  3. Recall initiated FDA recalls Z-1718-2025

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Biosorb
Generic name
Synthetic bone graft
Model / Ref / Catalog
BIO1 Macroporous, P822893232
Primary DI / UDI-DI
03760154000710
510(k) Number
FDA product code
MQV
GMDN term
Synthetic bone graft
Device class
Class II
Regulation number
888.3045
GUDID distribution status
In Commercial Distribution
Size
Length — 4 Millimeter
Height — 4 Millimeter
Width — 4 Millimeter
Total Volume — 45 Milliliter

Related devices

Category: Synthetic bone graft

Cleared under the same submission (K021963)

and 5 more cleared under K021963

Similar devices in this category

Other devices filed under Synthetic bone graft.

Other devices from S.B.M

See all devices from S.B.M →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (8, all answered No)