AccuLIF TL and PL Cage
by Stryker Corporation 4 variants
510(k) K143616
AccuLIF TL and PL Cage is a Class II device made by Stryker Corporation, cleared under FDA 510(k) K143616 on 5 Mar 2015, active as of 22 Oct 2026. 4 FDA recalls are linked to it.
Active
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK143616 | Date5 Mar 2015 | StatusActive |
Official records
- FDA 510(k) database K143616
Recalls
-
- Terminated Z-2788-2016
- Terminated Z-2787-2016
- Terminated Z-2786-2016
Since Stryker acquired the AccuLIF product in March of 2014, there have been Product Inquires (PIs) related to the PL implant confirming to have a reduction of height > 1 mm. The current occurrence rate for reported post-operative reduction of cage height (> 1mm) of AccuLIF PL Expandable Cages is approximately 0.47% and has demonstrated a slight upward trend since September 2015.
-
- Terminated Z-0852-2016
There were two potential interference conditions identified with the way the tubing set attaches to the inserter.
Timeline
- Cleared FDA 510(k) K143616
- Recall initiated FDA recalls Z-0852-2016
- Recall initiated FDA recalls Z-2788-2016
- Recall initiated FDA recalls Z-2787-2016
- Recall initiated FDA recalls Z-2786-2016
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- MAX
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3080
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent