# K120352: Stryker Quikflap Sterile Procedure Pack

- Pathway: 510(k) (Special)
- Applicant: Stryker
- Decided: Jun 11, 2012 after 126 days
- Product code: GWO (Plate, Cranioplasty, Preformed, Alterable)
- Device class: 2
- Regulation: 21 CFR 882.5320
- Recalls of this device: 18 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K761228 (1976). 30 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112557: Stryker Universal Neuro 3 System, Stryker (2012) Summary page 1.

## Most influential descendants
- K140309: Cranioplug (2014), 2 descendants of its own
- K181539: OSSDSIGN Cranioplug (2018), 1 descendant of its own
- K253447: Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover) (2026), 0 descendants of its own
- K131775: Universal Neuro 3 System (2013), 0 descendants of its own

## Recalls of this device
- Jun 22, 2018 · Class II · Z-2899-2018: After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.
- Jun 22, 2018 · Class II · Z-2913-2018: After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.
- Jun 22, 2018 · Class II · Z-2898-2018: After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.
- Jun 22, 2018 · Class II · Z-2900-2018: After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.
- Jun 22, 2018 · Class II · Z-2910-2018: After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.
- Jun 22, 2018 · Class II · Z-2901-2018: After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.
- Jun 22, 2018 · Class II · Z-2903-2018: After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.
- Jun 22, 2018 · Class II · Z-2912-2018: After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.
- Jun 22, 2018 · Class II · Z-2904-2018: After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.
- Jun 22, 2018 · Class II · Z-2907-2018: After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.
- Jun 22, 2018 · Class II · Z-2911-2018: After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.
- Jun 22, 2018 · Class II · Z-2905-2018: After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.
- Jun 22, 2018 · Class II · Z-2906-2018: After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.
- Jun 22, 2018 · Class II · Z-2909-2018: After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.
- Jun 22, 2018 · Class II · Z-2914-2018: After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.
- Jun 22, 2018 · Class II · Z-2908-2018: After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.
- Jun 22, 2018 · Class II · Z-2902-2018: After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.
- Jun 22, 2018 · Class II · Z-2915-2018: After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.

## Indications for use
The Stryker QuikFiap Sterile Procedure Pack is intended for reconstruction, stabilization and/or rigid fixation of non load-bearing bony areas subsequent to craniotomy, craniectomy and cranial fractures in adults and adolescents (age 12 and higher).

Source page: https://510kreport.com/device/K120352
Methodology: https://510kreport.com/methodology