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Endoskeleton TCS 5386-1606-N

by Titan Spine, Inc.

Endoskeleton TCS 5386-1606-N is a Class II device made by Titan Spine, Inc., cleared under FDA 510(k) K153122 on 14 Dec 2015 (1 earlier submission) and listed in FDA GUDID since 11 Jan 2016 (UDI-DI M68253861606N0), active (FDA 510(k)), not in commercial distribution (GUDID) as of 23 Oct 2026. 3 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

3 closed

Documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberM68253861606N0 UDI-DI Date11 Jan 2016ListedStatusListed GUDID: not in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK153122 Date14 Dec 2015DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K153122 decided 14 Dec 2015 Active· +1 more in the status table
  • FDA GUDID UDI-DI M68253861606N0 listed 11 Jan 2016 Listed

Recalls

3 recalls · FDA

    • Terminated Z-0086-2022 FDA Class II initiated 2 Sep 2021

    Engraving on implants may not match what is listed on the pouch labels.

    • 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

6 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. Cleared FDA 510(k) K153122
  5. Listed FDA GUDID M68253861606N0
  6. Recall initiated FDA recalls Z-0086-2022

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  • Withdrawn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
5386-1606-N
Primary DI / UDI-DI
M68253861606N0
510(k) Number
FDA product code
ODP, OVE
GMDN term
Metallic spinal interbody fusion cage
Device class
Class II
Regulation number
888.3080
GUDID distribution status
Not in Commercial Distribution
Size
Height — 6 Millimeter
Width — 18 Millimeter
Depth — 16 Millimeter
Angle — 6 degree

Related devices

Cleared under the same submission (K142940)

and 8 more cleared under K142940

Cleared under the same submission (K153122)

and 8 more cleared under K153122

Similar devices

Other devices filed under FDA product code ODP (Intervertebral fusion device with bone graft, cervical).

Other devices from Titan Spine, Inc.

See all devices from Titan Spine, Inc. →

Properties

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