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X-Stop Interspinous Process Decompression System

by Medtronic Sofamor Danek, Inc.

PMA P040001

X-Stop Interspinous Process Decompression System is a Class III device made by Medtronic Sofamor Danek, Inc., approved under FDA PMA P040001 on 21 Nov 2005, withdrawn as of 6 Oct 2026. 2 FDA recalls are linked to it.

Withdrawn Withdrawn in United States.

Was authorized under PMA, withdrawn

Ended

Withdrawn 21 Nov 2005

PMA

FDA recalls

None ongoing

2 closed

Documents

Trust

Unverified

Source FDA PMA, synced 6 Oct 2026.

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPWD Approval withdrawn NumberP040001 Date21 Nov 2005Approval withdrawnStatusWithdrawn

Official records

Recalls

2 recalls · FDA

    • Terminated Z-1765-2008 FDA Unclassified (pre-2012) initiated 30 Jan 2008

    Physician instructions revised due to product breakage: During the implantation of the X-STOP IPD Device, the product has the potential to cause damage to and/or breakage of the X-STOP IPD Device's universal wing assembly. This includes the potential for breakage of the wing screw.

    • Terminated Z-1258-06 FDA Unclassified (pre-2012) initiated 6 Jun 2006

    Some units may be mislabeled as 10 mm X STOP implant that actually contain 14 mm X STOP implant.

Timeline

3 dated events

  1. Approved FDA PMA P040001
  2. Recall initiated FDA recalls Z-1258-06
  3. Recall initiated FDA recalls Z-1765-2008

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA PMA Withdrawn

Specification

PMA

Full name
X-Stop Ipd System
Trade name
X Stop Interspinous Process Decompression System
Generic name
Prosthesis, spinous process spacer/plate
PMA number
FDA product code
NQO
Device class
Class III
Advisory committee
Orthopedic
FDA decision
APWD Approval withdrawn

Devices cleared under P040001

71 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 P040001
UDI-DISize and differences
X-STOP® Interspinous Spacer 1-2206
MEDTRONIC SOFAMOR DANEK, INC.
1-220600643169132740
Single use: yes
On the market
X-STOP® Interspinous Spacer 1-2208
MEDTRONIC SOFAMOR DANEK, INC.
1-220800613994598677
Single use: yes
No longer on the market
X-STOP® Interspinous Spacer 1-2208
MEDTRONIC SOFAMOR DANEK, INC.
1-220800643169132733
Single use: yes
No longer on the market
X-STOP® Interspinous Spacer 1-2210
MEDTRONIC SOFAMOR DANEK, INC.
1-221000858196001895
Single use: yes
On the market
X-STOP® Interspinous Spacer 1-2210
MEDTRONIC SOFAMOR DANEK, INC.
1-221000643169132726
Single use: yes
On the market
X-STOP® Interspinous Spacer 1-2212
MEDTRONIC SOFAMOR DANEK, INC.
1-221200613994598691
Single use: yes
On the market
X-STOP® Interspinous Spacer 1-2214
MEDTRONIC SOFAMOR DANEK, INC.
1-221400613994598707
Single use: yes
On the market
X-STOP® Interspinous Spacer 1-3206
MEDTRONIC SOFAMOR DANEK, INC.
1-320600643169132856
Single use: yes
On the market
X-STOP® Interspinous Spacer 1-3206
MEDTRONIC SOFAMOR DANEK, INC.
1-320600613994598714
Single use: yes
On the market
X-STOP® Interspinous Spacer 1-3208
MEDTRONIC SOFAMOR DANEK, INC.
1-320800613994598721
Single use: yes
On the market
X-STOP® Interspinous Spacer 1-3208
MEDTRONIC SOFAMOR DANEK, INC.
1-320800643169132849
Single use: yes
On the market
X-STOP® Interspinous Spacer 1-3210
MEDTRONIC SOFAMOR DANEK, INC.
1-321000613994598738
Single use: yes
On the market
X-STOP® Interspinous Spacer 1-3210
MEDTRONIC SOFAMOR DANEK, INC.
1-321000643169132832
Single use: yes
On the market
X-STOP® Interspinous Spacer 1-3212
MEDTRONIC SOFAMOR DANEK, INC.
1-321200643169132825
Single use: yes
On the market
X-STOP® Interspinous Spacer 1-3214
MEDTRONIC SOFAMOR DANEK, INC.
1-321400613994598653
Single use: yes
On the market
X-STOP® Interspinous Spacer 1-3214
MEDTRONIC SOFAMOR DANEK, INC.
1-321400643169132818
Single use: yes
On the market
X-STOP® Interspinous Spacer 1-3216
MEDTRONIC SOFAMOR DANEK, INC.
1-321600643169132801
Single use: yes
On the market
X-STOP® Interspinous Spacer 1-3216
MEDTRONIC SOFAMOR DANEK, INC.
1-321600613994598547
Single use: yes
On the market
X-STOP® Interspinous Spacer 2-2001
MEDTRONIC SOFAMOR DANEK, INC.
2-200100643169117761
Single use: no
On the market
X-STOP® Interspinous Spacer 2-2002
MEDTRONIC SOFAMOR DANEK, INC.
2-200200613994598561
Single use: no
On the market
X-STOP® Interspinous Spacer 2-2002
MEDTRONIC SOFAMOR DANEK, INC.
2-200200613994455482
Single use: no
On the market
X-STOP® Interspinous Spacer 2-2003
MEDTRONIC SOFAMOR DANEK, INC.
2-200300843889000200
Single use: no
On the market
X-STOP® Interspinous Spacer 2-2003
MEDTRONIC SOFAMOR DANEK, INC.
2-200300613994455475
Single use: no
On the market
X-STOP® Interspinous Spacer 2-2003
MEDTRONIC SOFAMOR DANEK, INC.
2-200300613994598578
Single use: no
On the market
X-STOP® Interspinous Spacer 2-2003
MEDTRONIC SOFAMOR DANEK, INC.
2-200300643169117747
Single use: no
On the market
X-STOP® Interspinous Spacer 2-2004
MEDTRONIC SOFAMOR DANEK, INC.
2-200400613994455468
Single use: no
On the market
X-STOP® Interspinous Spacer 2-2004
MEDTRONIC SOFAMOR DANEK, INC.
2-200400643169117730
Single use: no
On the market
X-STOP® Interspinous Spacer 2-2004
MEDTRONIC SOFAMOR DANEK, INC.
2-200400613994598585
Single use: no
On the market
X-STOP® Interspinous Spacer 2-2005
MEDTRONIC SOFAMOR DANEK, INC.
2-200500643169117723
Single use: no
On the market
X-STOP® Interspinous Spacer 2-2005
MEDTRONIC SOFAMOR DANEK, INC.
2-200500613994455451
Single use: no
On the market
X-STOP® Interspinous Spacer 2-2016
MEDTRONIC SOFAMOR DANEK, INC.
2-201600613994455444
Single use: no
On the market
X-STOP® Interspinous Spacer 2-2301
MEDTRONIC SOFAMOR DANEK, INC.
2-230100843889000217
Single use: no
On the market
X-STOP® Interspinous Spacer 2-2301
MEDTRONIC SOFAMOR DANEK, INC.
2-230100613994455437
Single use: no
On the market
X-STOP® Interspinous Spacer 2-2301
MEDTRONIC SOFAMOR DANEK, INC.
2-230100643169117709
Single use: no
On the market
X-STOP® Interspinous Spacer 2-4001
MEDTRONIC SOFAMOR DANEK, INC.
2-400100643169117686
Single use: no
On the market
X-STOP® Interspinous Spacer 2-4010
MEDTRONIC SOFAMOR DANEK, INC.
2-401000643169117662
Single use: no
On the market
X-STOP® Interspinous Spacer 2-4010
MEDTRONIC SOFAMOR DANEK, INC.
2-401000613994580078
Single use: no
On the market
X-STOP® Interspinous Spacer 2-4012
MEDTRONIC SOFAMOR DANEK, INC.
2-401200643169117655
Single use: no
On the market
X-STOP® Interspinous Spacer 2-4014
MEDTRONIC SOFAMOR DANEK, INC.
2-401400643169117648
Single use: no
On the market
X-STOP® Interspinous Spacer 2-4016
MEDTRONIC SOFAMOR DANEK, INC.
2-401600613994580139
Single use: no
On the market
X-STOP® Interspinous Spacer 2-4016
MEDTRONIC SOFAMOR DANEK, INC.
2-401600643169117631
Single use: no
On the market
X-STOP® Interspinous Spacer 2-4116
MEDTRONIC SOFAMOR DANEK, INC.
2-411600643169117624
Single use: no
On the market
X-STOP® Interspinous Spacer 2-4301
MEDTRONIC SOFAMOR DANEK, INC.
2-430100613994579898
Single use: no
On the market
X-STOP® Interspinous Spacer 2-4301
MEDTRONIC SOFAMOR DANEK, INC.
2-430100643169117617
Single use: no
On the market
X-STOP® Interspinous Spacer 3-3001
MEDTRONIC SOFAMOR DANEK, INC.
3-300100643169117600
Single use: no
On the market
X-STOP® Interspinous Spacer 3-4001
MEDTRONIC SOFAMOR DANEK, INC.
3-400100613994579904
Single use: no
On the market
X-STOP® Interspinous Spacer 4-2000
MEDTRONIC SOFAMOR DANEK, INC.
4-200000843889000125
Single use: no
On the market
X-STOP® Interspinous Spacer 4-2000
MEDTRONIC SOFAMOR DANEK, INC.
4-200000643169117587
Single use: no
On the market
X-STOP® Interspinous Spacer 4-5500
MEDTRONIC SOFAMOR DANEK, INC.
4-550000643169117549
Single use: no
No longer on the market
X-STOP® Interspinous Spacer 4-5500
MEDTRONIC SOFAMOR DANEK, INC.
4-550000613994579980
Single use: no
On the market

Similar devices

Other devices filed under FDA product code NQO (Prosthesis, Spinous Process Spacer/Plate).

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