510(k) · Cleared
ClearedSynthes Afs
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synthes Spine · NQW Orthosis, Spine, Plate, Laminoplasty, Metal
Cleared on Apr 1, 2004 as substantially equivalent to K963741 (Howmedica Leibinger, Inc., 1997) and 3 other predicates after a 230-day review. Its family tree reaches back 2 generations to 1976. 43 later devices descend from it.
- Decided
- Apr 1, 2004
- Review
- 230 days
- Class
- Class II
- Product code
- NQW
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K761228 (1976). 10 ancestors in all. 43 later devices descend from it, 18 citing it directly.
- Root · 2 generations backK761228 Luhr Mandibular Compression-Screw SystemHowmedica Corp. · 1976
- 1 generation backK963741 Leibinger Luhr Small Craniomaxillofacial Bone ScrewsHowmedica Leibinger, Inc. · 1997
- This deviceK032534 Synthes AfsSynthes Spine · 2004
- Descendant · cites it directly · 17 of its ownK091994 Mountaineer Laminoplasty SystemDepuy Spine, Inc. · 2010
- Descendant · cites it directly · 17 of its ownK043338 Blakstone Laminoplasty Fixation SystemBlackstone Medical, Inc. · 2005
- Descendant · cites it directly · 11 of its ownK080664 Relieve Laminoplasty Fixation SystemGlobus Medical, Inc. · 2008
- Descendant · 2 generations on · 10 of its ownK121732 Canopy Laminoplasty Fixation SystemGlobus Medical, Inc. · 2012
- Descendant · cites it directly · 7 of its ownK113802 Escalate Laminoplasty SystemStryker Spine · 2012
Showing 5 of 43 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 43 · See all- K091994Mountaineer Laminoplasty SystemDepuy Spine, Inc. · 2010 · cites it directly17descendants
- K043338Blakstone Laminoplasty Fixation SystemBlackstone Medical, Inc. · 2005 · cites it directly17descendants
- K080664Relieve Laminoplasty Fixation SystemGlobus Medical, Inc. · 2008 · cites it directly11descendants
- K121732Canopy Laminoplasty Fixation SystemGlobus Medical, Inc. · 2012 · 2 generations on10descendants
- K113802Escalate Laminoplasty SystemStryker Spine · 2012 · cites it directly7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K761228 | Luhr Mandibular Compression-Screw System | Howmedica Corp. | 1976 | — |
| −1 | K963741 | Leibinger Luhr Small Craniomaxillofacial Bone Screws | Howmedica Leibinger, Inc. | 1997 | — |
| 0 (this device) | K032534 | Synthes Afs | Synthes Spine | 2004 | — |
| +1 | K091994 | Mountaineer Laminoplasty System | Depuy Spine, Inc. | 2010 | — |
| +1 | K043338 | Blakstone Laminoplasty Fixation System | Blackstone Medical, Inc. | 2005 | — |
| +1 | K080664 | Relieve Laminoplasty Fixation System | Globus Medical, Inc. | 2008 | — |
| +2 | K121732 | Canopy Laminoplasty Fixation System | Globus Medical, Inc. | 2012 | — |
| +1 | K113802 | Escalate Laminoplasty System | Stryker Spine | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1986 | 2 | 0 |
| 1988 | 1 | 0 |
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
| 1996 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 3 | 0 |
| 2012 | 5 | 0 |
| 2013 | 3 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 4 | 0 |
| 2019 | 3 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 3 | 0 |
| 2024 | 7 | 0 |
| 2026 | 4 | 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 NQW? 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 NQW device
- #1 K243137 Curiteva Porous PEEK Laminoplasty Systemscore 13.1 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K963741 | Leibinger Luhr Small Craniomaxillofacial Bone ScrewsSummary page 1…sis. Product code: NQW COMMON NAME: Appliance, fixation, interlaminal PREDICATE DEVICE: Plate, fixation, bone: K963741 - Howmedica Leibinger Inc. K961485 - Howmedica Inc. K961497 - Howmedica Inc.… | 1997 |
| * | K961485 | Forefoot Reconstruction SystemSummary page 1…E: Appliance, fixation, interlaminal PREDICATE DEVICE: Plate, fixation, bone: K963741 - Howmedica Leibinger Inc. K961485 - Howmedica Inc. K961497 - Howmedica Inc. Bone fixation Cerclage:… | 1996 |
| * | K961497 | Profyle Titanium Hand and Small Fragment SystemSummary page 1…REDICATE DEVICE: Plate, fixation, bone: K963741 - Howmedica Leibinger Inc. K961485 - Howmedica Inc. K961497 - Howmedica Inc. Bone fixation Cerclage: K850631 - Kirschner Medical Corp. DEVICE… | 1996 |
| * | K850631 | Kirschner Orthopedic Wire, Eyelet Cerclage WiresSummary page 1…er Inc. K961485 - Howmedica Inc. K961497 - Howmedica Inc. Bone fixation Cerclage: K850631 - Kirschner Medical Corp. DEVICE The Synthes AFS is comprised of various sized, pre-bent mini- DESCRIPTION:… | 1985 |
What descends from it? (43)
See all 4318 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K091994 | Mountaineer Laminoplasty System | 2010 | 17 |
| K043338 | Blakstone Laminoplasty Fixation System | 2005 | 17 |
| K080664 | Relieve Laminoplasty Fixation System | 2008 | 11 |
| K113802 | Escalate Laminoplasty System | 2012 | 7 |
| K091623 | Laminoplasty Fixation System | 2009 | 7 |
| K122822 | Spectrum Spine Laminoplasty Plating System | 2013 | 5 |
| K173215 | Choice Spine Laminoplasty™ Fixation System | 2018 | 4 |
| K100805 | Gallery Laminoplasty Fixation System | 2010 | 3 |
| K231232 | Curiteva Laminoplasty System | 2023 | 2 |
| K090354 | Laminoplasty Plating System | 2009 | 2 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 28 years and passes through 3 companies; a new generation was cleared every 20.1 years on median.
- 1 of the 10 ancestors has a recall of any class.
- Of its descendants, K091994 (Depuy Spine, Inc., 2010) has gone furthest, with 17 descendants of its own.
- 1 other device also cites its predicate K963741.
How does its category compare?
All NQW devicesNQW Orthosis, Spine, Plate, Laminoplasty, Metal: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NQW
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · NQW
84in 2013
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NQW
No recall names NQW since 2007.
Adverse event reports per year · NQW
33in 2025
MAUDE reports naming product code NQW, 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 | 0 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 2 |
| 2010 | 3 | 120 | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 4 | 120 | 0 | 1 |
| 2013 | 3 | 84 | 0 | 49 |
| 2014 | 0 | — | 0 | 5 |
| 2015 | 1 | — | 0 | 11 |
| 2016 | 2 | — | 0 | 7 |
| 2017 | 1 | — | 0 | 19 |
| 2018 | 2 | — | 0 | 5 |
| 2019 | 2 | — | 0 | 8 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 1 | — | 0 | 7 |
| 2022 | 0 | — | 0 | 16 |
| 2023 | 2 | — | 0 | 5 |
| 2024 | 2 | — | 0 | 15 |
| 2025 | 0 | — | 0 | 33 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Synthes ArchTM Fixation System is intended for use in the lower cervical and upper thoracic spine (C3-T3) after a laminoplasty has been performed. The Arch TM Fixation System holds or buttresses the allograft in place in order to prevent the allograft from expulsion or impinging on the spinal cord.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032534 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032534: Synthes Afs.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032534
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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