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Endoskeleton TCS 5386-1608

by Titan Spine, Inc.

Endoskeleton TCS 5386-1608 is a Class II device made by Titan Spine, Inc., cleared under FDA 510(k) K142940 on 28 Jan 2015 and listed in FDA GUDID since 17 Sep 2015 (UDI-DI M682538616080), active (FDA 510(k)), not in commercial distribution (GUDID) as of 23 Oct 2026. 2 FDA recalls are linked to it.

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 ongoing

2 closed

Documents

510(k) K142940

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 NumberM682538616080 UDI-DI Date17 Sep 2015ListedStatusListed GUDID: not in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK142940 Date28 Jan 2015DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K142940 decided 28 Jan 2015 Active
  • FDA GUDID UDI-DI M682538616080 listed 17 Sep 2015 Listed

Recalls

2 recalls · FDA

    • Terminated Z-2327-2015 FDA Class II initiated 20 Jul 2015

    Titan Spine is recalling specific Endoskeleton TCS Integrated Locking Bone Screw Assembly due to the locking bone screw collars not 'locking'.

    • Terminated Z-1324-2015 FDA Class II initiated 20 Feb 2015

    The TCS Straight Hexlobular #6 Drivers (5210-1004) tip sheared off during use in procedures that involved patients with dense bones. As a result of this malfunction, Titan Spine, LLC is removing all of the TCS Straight Hex lobular #6 Drivers (5210-1004) Lot# G150101 from the field.

Timeline

4 dated events

  1. Cleared FDA 510(k) K142940
  2. Recall initiated FDA recalls Z-1324-2015
  3. Recall initiated FDA recalls Z-2327-2015
  4. Listed FDA GUDID M682538616080

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Endoskeleton TCS
Generic name
Metallic spinal interbody fusion cage
Model / Ref / Catalog
5386-1608
Primary DI / UDI-DI
M682538616080
510(k) Number
FDA product code
OVE, ODP
GMDN term
Metallic spinal interbody fusion cage
Device class
Class II
Regulation number
888.3080
GUDID distribution status
Not in Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization
Size
Height — 8 Millimeter
Depth — 16 Millimeter
Width — 18 Millimeter
Angle — 6 degree

Related devices

Cleared under the same submission (K142940)

and 8 more cleared under K142940

Similar devices

Other devices filed under FDA product code OVE (Intervertebral fusion device with integrated fixation, cervical).

Other devices from Titan Spine, Inc.

See all devices from Titan Spine, Inc. →

Properties

  • Sterilise before use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (10, all answered No)