Skip to content

Ballast 02-8000-115

by Isotis Orthobiologics, Inc

Ballast 02-8000-115 is a Class II device made by Isotis Orthobiologics, Inc, cleared under FDA 510(k) K172130 on 16 Nov 2017 and listed in FDA GUDID since 5 Apr 2018 (UDI-DI 10889981149321), 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) K172130

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 Number10889981149321 UDI-DI Date5 Apr 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK172130 Date16 Nov 2017DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K172130 decided 16 Nov 2017 Active
  • FDA GUDID UDI-DI 10889981149321 listed 5 Apr 2018 Listed

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-2820-2026 FDA Class II initiated 2 Jul 2026

    Demineralized bone matrix (DBM) in resorbable mesh indicated for use with autograft as a bone graft extender in the posterolateral spine and pelvis, were filled with approx. 4.5 cc DBM (fill for 45 11 mm configuration) instead of approx. 7.5 cc DBM (fill for 45 17.5 mm configuration), which may lead to delayed fusion, incomplete fusion, pseudarthrosis, or lack of bone ingrowth.

Timeline

3 dated events

  1. Cleared FDA 510(k) K172130
  2. Listed FDA GUDID 10889981149321
  3. Recall initiated FDA recalls Z-2820-2026

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Ballast
Generic name
Human-derived demineralized bone matrix implant
Model / Ref / Catalog
02-8000-115
Primary DI / UDI-DI
10889981149321
510(k) Number
FDA product code
MBP, MQV
GMDN term
Human-derived demineralized bone matrix implant
Device class
Class II
Regulation number
888.3045
GUDID distribution status
In Commercial Distribution

Related devices

Category: Bone matrix implant, human-derived

Cleared under the same submission (K172130)

and 3 more cleared under K172130

Similar devices

Other devices filed under FDA product code MBP (Filler, bone void, osteoinduction (w/o human growth factor)).

Other devices from Isotis Orthobiologics, Inc

See all devices from Isotis Orthobiologics, Inc →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • HCT/P
  • Lot / batch number
  • Serial number
  • Expiration date
Other properties (7, all answered No)