510(k) · Cleared
Recalled · Class II · 2018Stryker Quikflap Sterile Procedure Pack
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker · GWO Plate, Cranioplasty, Preformed, Alterable
Cleared on Jun 11, 2012 as substantially equivalent to K112557 (Stryker, 2012) after a 126-day review. Its family tree reaches back 7 generations to 1976. 4 later devices descend from it. It has been recalled 18 times.
- Decided
- Jun 11, 2012
- Review
- 126 days
- Class
- Class II
- Product code
- GWO
- Recalls
- 18
- Predicates
- 1
Its longest line of descent runs back 7 generations to K761228 (1976). 30 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK761228 Luhr Mandibular Compression-Screw SystemHowmedica Corp. · 1976
- 6 generations backK963739 Leibinger - Luhr Small Orthopedic Bone ScrewsHowmedica Leibinger, Inc. · 1997
- 5 generations backK970912 Leibinger Self-Drilling ScrewHowmedica Leibinger, Inc. · 1997
- 4 generations backK974785 Auto-Drive Bone ScrewOsteomed Corp. · 1998
- 3 generations backK023260 1.2MM Osteomed Auto-Drive Screw SystemOsteomed Corp. · 2002
- 2 generations backK031659 Universal Neuro SystemStryker Instruments · 2003
- 1 generation backK112557 Stryker Universal Neuro 3 SystemStryker · 2012
- This deviceK120352 Stryker Quikflap Sterile Procedure PackStryker · 2012
- Descendant · cites it directly · 2 of its ownK140309 CranioplugOssdsign AB · 2014
- Descendant · 2 generations on · 1 of its ownK181539 OSSDSIGN CranioplugOssdsign AB · 2018
- Descendant · 3 generations on · 0 of its ownK253447 Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover)Orthocon, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK131775 Universal Neuro 3 SystemStryker · 2013
Most influential descendants
Showing 4 of 4 · See all- K140309CranioplugOssdsign AB · 2014 · cites it directly2descendants
- K181539OSSDSIGN CranioplugOssdsign AB · 2018 · 2 generations on1descendant
- K253447Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover)Orthocon, Inc. · 2026 · 3 generations on0descendants
- K131775Universal Neuro 3 SystemStryker · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K761228 | Luhr Mandibular Compression-Screw System | Howmedica Corp. | 1976 | — |
| −6 | K963739 | Leibinger - Luhr Small Orthopedic Bone Screws | Howmedica Leibinger, Inc. | 1997 | — |
| −5 | K970912 | Leibinger Self-Drilling Screw | Howmedica Leibinger, Inc. | 1997 | — |
| −4 | K974785 | Auto-Drive Bone Screw | Osteomed Corp. | 1998 | — |
| −3 | K023260 | 1.2MM Osteomed Auto-Drive Screw System | Osteomed Corp. | 2002 | — |
| −2 | K031659 | Universal Neuro System | Stryker Instruments | 2003 | — |
| −1 | K112557 | Stryker Universal Neuro 3 System | Stryker | 2012 | — |
| 0 (this device) | K120352 | Stryker Quikflap Sterile Procedure Pack | Stryker | 2012 | — |
| +1 | K140309 | Cranioplug | Ossdsign AB | 2014 | — |
| +2 | K181539 | OSSDSIGN Cranioplug | Ossdsign AB | 2018 | — |
| +3 | K253447 | Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover) | Orthocon, Inc. | 2026 | — |
| +1 | K131775 | Universal Neuro 3 System | Stryker | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 3 | 0 |
| 1988 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 3 | 0 |
| 1996 | 5 | 0 |
| 1997 | 1 | 0 |
| 1998 | 3 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2018 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GWO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new GWO device
- #1 K261058 CraniUS Platescore 16.8 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K112557 | Stryker Universal Neuro 3 SystemSummary page 1…er HIBW - Cranioplasty plate fastener Predicate Device: Stryker Universal Neuro 3 system - K1 12557 Page 1 of 8 For… | 2012 |
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 22, 2018 | Class II | Z-2899-2018 | Package design/selection | 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 | Package design/selection | 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 | Package design/selection | 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 | Package design/selection | 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 | Package design/selection | 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 | Package design/selection | 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 | Package design/selection | 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 | Package design/selection | 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 | Package design/selection | 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 | Package design/selection | 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 | Package design/selection | 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 | Package design/selection | 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 | Package design/selection | 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 | Package design/selection | 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 | Package design/selection | 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 | Package design/selection | 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 | Package design/selection | 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 | Package design/selection | After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised. |
The 5 latest of 18 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 36 years and passes through 5 companies; a new generation was cleared every 11 months on median.
- 2 of the 30 ancestors have a recall of any class.
- Of its descendants, K140309 (Ossdsign AB, 2014) has gone furthest, with 2 descendants of its own.
- 3 other devices also cite its predicate K112557.
How does its category compare?
All GWO devicesGWO Plate, Cranioplasty, Preformed, Alterable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · GWO
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GWO
196in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GWO
2in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GWO
237in 2025
MAUDE reports naming product code GWO, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 1 | 0 |
| 2008 | 1 | — | 0 | 3 |
| 2009 | 0 | — | 0 | 2 |
| 2010 | 1 | — | 0 | 7 |
| 2011 | 2 | — | 0 | 1 |
| 2012 | 5 | 133 | 0 | 5 |
| 2013 | 4 | 249 | 0 | 7 |
| 2014 | 3 | 109 | 0 | 11 |
| 2015 | 3 | 210 | 2 | 18 |
| 2016 | 3 | 125 | 0 | 18 |
| 2017 | 2 | — | 0 | 47 |
| 2018 | 1 | — | 0 | 41 |
| 2019 | 4 | 196 | 0 | 14 |
| 2020 | 0 | — | 0 | 25 |
| 2021 | 1 | — | 0 | 41 |
| 2022 | 2 | — | 0 | 53 |
| 2023 | 0 | — | 0 | 72 |
| 2024 | 1 | — | 0 | 149 |
| 2025 | 2 | — | 0 | 237 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
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).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120352 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120352: Stryker Quikflap Sterile Procedure Pack.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120352
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026