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Optecure

by Exactech, Inc.

510(k) K050806

Optecure is a Class II device made by Exactech, Inc., cleared under FDA 510(k) K121989 on 27 Nov 2012 (3 earlier submissions) and listed in FDA GUDID since 17 Jul 2016 (UDI-DI 10885862094797), active (FDA 510(k)), not in commercial distribution (GUDID) as of 22 Oct 2026.

Active United States. Also listed in GUDID (US), not in commercial distribution.

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number10885862094797 UDI-DI Date17 Jul 2016ListedStatusListed GUDID: not in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK121989 Date27 Nov 2012DecidedStatusActive
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK050806 Date8 Feb 2006ClearedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K121989 decided 27 Nov 2012 Active· +3 more in the status table
  • FDA GUDID UDI-DI 10885862094797 listed 17 Jul 2016 Listed

Timeline

5 dated events

  1. Cleared FDA 510(k) K040755
  2. Cleared FDA 510(k) K050806
  3. Cleared FDA 510(k) K103699
  4. Cleared FDA 510(k) K121989
  5. Listed FDA GUDID 10885862094797

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k) · GUDID

Generic name
Human-derived demineralized bone matrix implant
Model / Ref / Catalog
650-00-02
Primary DI / UDI-DI
10885862094797
510(k) Number
FDA product code
MBP, NUN, MQV
GMDN term
Human-derived demineralized bone matrix implant
Device class
Class II
Regulation
21 CFR Part 888.3045 510(k)GUDID
872.3930 GUDID
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent
GUDID distribution status
Not in Commercial Distribution

Related clearances

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Devices cleared under K050806

10 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K050806
UDI-DISize and differences
Entice 690-00-01
Exactech, Inc.
690-00-01 / 690-00-0110885862252845 —No longer on the market
Entice 690-00-02
Exactech, Inc.
690-00-02 / 690-00-0210885862252852 —On the market
Entice 690-00-05
Exactech, Inc.
690-00-05 / 690-00-0510885862252869 —On the market
Entice 690-00-10
Exactech, Inc.
690-00-10 / 690-00-1010885862252876 —On the market
Entice 690-00-20
Exactech, Inc.
690-00-20 / 690-00-2010885862252883 —On the market
OpteCure 650-00-01
Exactech, Inc.
650-00-01 / 650-00-0110885862094780 —On the market
OpteCure 650-00-02
Exactech, Inc.
650-00-02 / 650-00-0210885862094797 —No longer on the market
OpteCure 650-00-05
Exactech, Inc.
650-00-05 / 650-00-0510885862094803 —On the market
OpteCure 650-00-10
Exactech, Inc.
650-00-10 / 650-00-1010885862094810 —On the market
Optecure 650-00-20
Exactech, Inc.
650-00-20 / 650-00-2010885862094827 —No longer on the market

Similar devices

Other devices filed under FDA product code MBP (Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)).

Other devices from Exactech, Inc.

See all devices from Exactech, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • HCT/P
  • Serial number
  • Expiration date
Other properties (8, all answered No)