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Endoskeleton TCS System

by Titan Spine, LLC

510(k) K142940

Endoskeleton TCS System is a Class II device made by Titan Spine, LLC, cleared under FDA 510(k) K142940 on 28 Jan 2015, active as of 22 Oct 2026. 2 FDA recalls are linked to it.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 closed

Documents

Trust

Unverified

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

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK142940 Date28 Jan 2015ClearedStatusActive

Official records

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

3 dated events

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

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
OVE
Device class
Class II
Regulation
21 CFR Part 888.3080
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

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

Cites

Cited by

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

Devices cleared under K142940

286 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 K142940
UDI-DISize and differences
ENDOSKELETON TCS 5086-1607
Titan Spine, Inc.
5086-1607 / 5086-1607M682508616070
Height 7 mm; Depth 16 mm; Width 18 mm; Angle 6 deg
Single use: no
No longer on the market
ENDOSKELETON TCS 5086-1609
Titan Spine, Inc.
5086-1609 / 5086-1609M682508616090
Height 9 mm; Width 18 mm; Angle 6 deg; Depth 16 mm
Single use: no
No longer on the market
Endoskeleton TCS 5301-3514
Titan Spine, Inc.
5301-3514 / 5301-3514M682530135140
Outer Diameter 3.5 mm; Length 14 mm
Single use: no
No longer on the market
Endoskeleton TCS 5301-3819
Titan Spine, Inc.
5301-3819 / 5301-3819M682530138190
Length 19 mm; Outer Diameter 3.5 mm
Single use: no
No longer on the market
Endoskeleton TCS 5340-1206
Titan Spine, Inc.
5340-1206 / 5340-1206M682534012060
Height 6 mm; Depth 12 mm; Width 14 mm
Single use: no
No longer on the market
Endoskeleton TCS 5340-1208-N
Titan Spine, Inc.
5340-1208-N / 5340-1208-NM68253401208N0
Height 8 mm; Width 14 mm; Depth 12 mm
Single use: yes
No longer on the market
Endoskeleton TCS 5340-1208-S
Titan Spine, Inc.
5340-1208-S / 5340-1208-SM68253401208S0
Height 8 mm; Width 14 mm; Depth 12 mm
Single use: yes
No longer on the market
Endoskeleton TCS 5340-1209-S
Titan Spine, Inc.
5340-1209-S / 5340-1209-SM68253401209S0
Height 9 mm; Depth 12 mm; Width 14 mm
Single use: yes
No longer on the market
Endoskeleton TCS 5340-1210-N
Titan Spine, Inc.
5340-1210-N / 5340-1210-NM68253401210N0
Height 10 mm; Width 14 mm; Depth 12 mm
Single use: yes
No longer on the market
Endoskeleton TCS 5346-1205-N
Titan Spine, Inc.
5346-1205-N / 5346-1205-NM68253461205N0
Height 5 mm; Width 14 mm; Depth 12 mm; Angle 6 deg
Single use: yes
No longer on the market
Endoskeleton TCS 5346-1208
Titan Spine, Inc.
5346-1208 / 5346-1208M682534612080
Height 8 mm; Depth 12 mm; Angle 6 deg; Width 14 mm
Single use: no
No longer on the market
Endoskeleton TCS 5346-1209
Titan Spine, Inc.
5346-1209 / 5346-1209M682534612090
Width 14 mm; Angle 6 deg; Depth 12 mm; Height 9 mm
Single use: no
No longer on the market
Endoskeleton TCS 5346-1209-S
Titan Spine, Inc.
5346-1209-S / 5346-1209-SM68253461209S0
Height 9 mm; Angle 6 deg; Width 14 mm; Depth 12 mm
Single use: yes
No longer on the market
Endoskeleton TCS 5346-1212
Titan Spine, Inc.
5346-1212 / 5346-1212M682534612120
Height 12 mm; Width 14 mm; Depth 12 mm; Angle 6 deg
Single use: no
No longer on the market
Endoskeleton TCS 5360-1405
Titan Spine, Inc.
5360-1405 / 5360-1405M682536014050
Height 5 mm; Depth 14 mm; Width 16 mm
Single use: no
No longer on the market
Endoskeleton TCS 5360-1405-N
Titan Spine, Inc.
5360-1405-N / 5360-1405-NM68253601405N0
Height 5 mm; Width 16 mm; Depth 14 mm
Single use: yes
No longer on the market
Endoskeleton TCS 5360-1406
Titan Spine, Inc.
5360-1406 / 5360-1406M682536014060
Height 6 mm; Width 16 mm; Depth 14 mm
Single use: no
No longer on the market
Endoskeleton TCS 5360-1406-S
Titan Spine, Inc.
5360-1406-S / 5360-1406-SM68253601406S0
Height 6 mm; Width 16 mm; Depth 14 mm
Single use: yes
No longer on the market
Endoskeleton TCS 5360-1407
Titan Spine, Inc.
5360-1407 / 5360-1407M682536014070
Height 7 mm; Depth 14 mm; Width 16 mm
Single use: no
No longer on the market
Endoskeleton TCS 5360-1408
Titan Spine, Inc.
5360-1408 / 5360-1408M682536014080
Height 8 mm; Width 16 mm; Depth 14 mm
Single use: no
No longer on the market
Endoskeleton TCS 5360-1408-N
Titan Spine, Inc.
5360-1408-N / 5360-1408-NM68253601408N0
Height 8 mm; Width 16 mm; Depth 14 mm
Single use: yes
No longer on the market
Endoskeleton TCS 5366-1405-N
Titan Spine, Inc.
5366-1405-N / 5366-1405-NM68253661405N0
Height 5 mm; Depth 14 mm; Angle 6 deg; Width 16 mm
Single use: yes
No longer on the market
Endoskeleton TCS 5366-1407-S
Titan Spine, Inc.
5366-1407-S / 5366-1407-SM68253661407S0
Height 7 mm; Depth 14 mm; Width 16 mm; Angle 6 deg
Single use: yes
No longer on the market
Endoskeleton TCS 5366-1410-S
Titan Spine, Inc.
5366-1410-S / 5366-1410-SM68253661410S0
Height 10 mm; Angle 6 deg; Depth 14 mm; Width 16 mm
Single use: yes
No longer on the market
Endoskeleton TCS 5366-1412-N
Titan Spine, Inc.
5366-1412-N / 5366-1412-NM68253661412N0
Height 12 mm; Width 16 mm; Depth 14 mm; Angle 6 deg
Single use: yes
No longer on the market
Endoskeleton TCS 5380-1610-S
Titan Spine, Inc.
5380-1610-S / 5380-1610-SM68253801610S0
Height 10 mm; Depth 16 mm; Width 18 mm
Single use: yes
No longer on the market
Endoskeleton TCS 5386-1608
Titan Spine, Inc.
5386-1608 / 5386-1608M682538616080
Height 8 mm; Depth 16 mm; Width 18 mm; Angle 6 deg
Single use: no
No longer on the market
Endoskeleton TCS 5386-1609-S
Titan Spine, Inc.
5386-1609-S / 5386-1609-SM68253861609S0
Height 9 mm; Width 18 mm; Angle 6 deg; Depth 16 mm
Single use: yes
No longer on the market
Endoskeleton TCS 5386-1610-N
Titan Spine, Inc.
5386-1610-N / 5386-1610-NM68253861610N0
Height 10 mm; Angle 6 deg; Width 18 mm; Depth 16 mm
Single use: yes
No longer on the market
ENDOSKELETON® TCS 5040-1209
Titan Spine, Inc.
5040-1209 / 5040-120900191375036272
Width 14 mm; Depth 12 mm; Height 9 mm
Single use: no
No longer on the market
ENDOSKELETON® TCS 5040-1211
Titan Spine, Inc.
5040-1211 / 5040-121100191375036289
Width 14 mm; Depth 12 mm; Height 11 mm
Single use: no
No longer on the market
ENDOSKELETON® TCS 5080-1611
Titan Spine, Inc.
5080-1611 / 5080-161100191375036340
Height 11 mm; Width 18 mm; Depth 16 mm
Single use: no
No longer on the market
ENDOSKELETON® TCS 5210-1017
Titan Spine, Inc.
5210-1017 / 5210-101700191375028345
Height 1 in; Width 2 in; Length 1.5 in
Single use: no
No longer on the market
ENDOSKELETON® TCS 5340-1210
Titan Spine, Inc.
5340-1210 / 5340-121000191375011149
Height 10 mm; Width 14 mm; Depth 12 mm
Single use: no
No longer on the market
ENDOSKELETON® TCS 5340-1212
Titan Spine, Inc.
5340-1212 / 5340-121200191375011163
Height 12 mm; Width 14 mm; Depth 12 mm
Single use: no
No longer on the market
ENDOSKELETON® TCS 5346-1208
MEDTRONIC SOFAMOR DANEK, INC.
5346-120800191375010883
Height 8 mm
Single use: yes
On the market
ENDOSKELETON® TCS 5360-1408
Titan Spine, Inc.
5360-1408 / 5360-140800191375011200
Height 8 mm; Depth 14 mm; Width 16 mm
Single use: no
No longer on the market
ENDOSKELETON® TCS 5360-1411
Titan Spine, Inc.
5360-1411 / 5360-141100191375011231
Width 16 mm; Depth 14 mm; Height 11 mm
Single use: no
No longer on the market
ENDOSKELETON® TCS 5366-1405
MEDTRONIC SOFAMOR DANEK, INC.
5366-140500191375010937
Depth 14 mm; Width 16 mm; Angle 6 deg; Height 5 mm
Single use: yes
On the market
ENDOSKELETON® TCS 5366-1406
MEDTRONIC SOFAMOR DANEK, INC.
5366-140600191375010944
Height 6 mm
Single use: yes
On the market
ENDOSKELETON® TCS 5366-1407
MEDTRONIC SOFAMOR DANEK, INC.
5366-140700191375010951
Height 7 mm
Single use: yes
On the market
ENDOSKELETON® TCS 5366-1408
MEDTRONIC SOFAMOR DANEK, INC.
5366-140800191375010968
Width 16 mm; Angle 6 deg; Depth 14 mm; Height 8 mm
Single use: yes
On the market
ENDOSKELETON® TCS 5366-1410
MEDTRONIC SOFAMOR DANEK, INC.
5366-141000191375010982
Height 10 mm
Single use: yes
On the market
ENDOSKELETON® TCS 5366-1411
MEDTRONIC SOFAMOR DANEK, INC.
5366-141100191375010999
Height 11 mm
Single use: yes
On the market
ENDOSKELETON® TCS 5380-1608
Titan Spine, Inc.
5380-1608 / 5380-160800191375011286
Height 8 mm; Depth 16 mm; Width 18 mm
Single use: no
No longer on the market
ENDOSKELETON® TCS 5386-1609
MEDTRONIC SOFAMOR DANEK, INC.
5386-160900191375011057
Angle 6 deg; Depth 16 mm; Width 18 mm; Height 9 mm
Single use: yes
On the market
ENDOSKELETON® TCS 5386-1611
MEDTRONIC SOFAMOR DANEK, INC.
5386-161100191375011071
Width 18 mm; Angle 6 deg; Depth 16 mm; Height 11 mm
Single use: yes
On the market
ENDOSKELETON® TCS 5386-1612
MEDTRONIC SOFAMOR DANEK, INC.
5386-161200191375011088
Angle 6 deg; Width 18 mm; Depth 16 mm; Height 12 mm
Single use: yes
On the market
ENDOSKELETON® TCS nanoLOCK® Surface Technology 5340-1208-N
Titan Spine, Inc.
5340-1208-N / 5340-1208-N00191375018636
Depth 12 mm; Width 14 mm; Height 8 mm
Single use: yes
No longer on the market
ENDOSKELETON® TCS nanoLOCK® Surface Technology 5380-1607-N
Titan Spine, Inc.
5380-1607-N / 5380-1607-N00191375018780
Depth 16 mm; Width 18 mm; Height 7 mm
Single use: yes
No longer on the market

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