510(k) · Cleared
ClearedLaminoplasy Plating System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aesculap Implant Systems, Inc. · NQW Orthosis, Spine, Plate, Laminoplasty, Metal
Cleared on Dec 2, 2010 as substantially equivalent to K090354 (Aesculap Implant System, Inc., 2009) and 1 other predicate after a 27-day review. Its family tree reaches back 4 generations to 1976. 1 later device descends from it.
- Decided
- Dec 2, 2010
- Review
- 27 days
- Class
- Class II
- Product code
- NQW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K761228 (1976). 12 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK761228 Luhr Mandibular Compression-Screw SystemHowmedica Corp. · 1976
- 3 generations backK963741 Leibinger Luhr Small Craniomaxillofacial Bone ScrewsHowmedica Leibinger, Inc. · 1997
- 2 generations backK032534 Synthes AfsSynthes Spine · 2004
- 1 generation backK090354 Laminoplasty Plating SystemAesculap Implant System, Inc. · 2009
- This deviceK103284 Laminoplasy Plating SystemAesculap Implant Systems, Inc. · 2010
- Descendant · cites it directly · 0 of its ownK160114 Xspan Laminoplasty Fixation SystemX-Spine Systems, Inc. · 2016
Most influential descendants
Showing 1 of 1 · See all- K160114Xspan Laminoplasty Fixation SystemX-Spine Systems, Inc. · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K761228 | Luhr Mandibular Compression-Screw System | Howmedica Corp. | 1976 | — |
| −3 | K963741 | Leibinger Luhr Small Craniomaxillofacial Bone Screws | Howmedica Leibinger, Inc. | 1997 | — |
| −2 | K032534 | Synthes Afs | Synthes Spine | 2004 | — |
| −1 | K090354 | Laminoplasty Plating System | Aesculap Implant System, Inc. | 2009 | — |
| 0 (this device) | K103284 | Laminoplasy Plating System | Aesculap Implant Systems, Inc. | 2010 | — |
| +1 | K160114 | Xspan Laminoplasty Fixation System | X-Spine Systems, Inc. | 2016 | — |
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 |
|---|---|---|
| 2016 | 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 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 13.0 · 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? (2)
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 |
|---|---|---|---|
| * | K090354 | Laminoplasty Plating SystemSummary page 1…SUBSTANTIAL EQUIVALENCE Aesculape Implant Systems (AIS) believes that the Laminoplasty Plating System is substantially equivalent to the AIS Laminoplasty Plating System (K090354) and the Synthes AFS (K032534). TECHNOLOGICAL CHARACTERSTICS(comoared to Predicate(s)) As established in this submission, the co… | 2009 |
| * | K032534 | Synthes AfsSummary page 1…ape Implant Systems (AIS) believes that the Laminoplasty Plating System is substantially equivalent to the AIS Laminoplasty Plating System (K090354) and the Synthes AFS (K032534). TECHNOLOGICAL CHARACTERSTICS(comoared to Predicate(s)) As established in this submission, the components of the AIS Laminoplas… | 2004 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K160114 | Xspan Laminoplasty Fixation System | 2016 | 0 |
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 34 years and passes through 5 companies; a new generation was cleared every 7.1 years on median.
- 1 of the 12 ancestors has a recall of any class.
- Of its descendants, K160114 (X-Spine Systems, Inc., 2016) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K090354.
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. 2010, this device’s year, is highlighted.
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 Aesculap Implant Systems Laminoplasty Plating System is intended for use in the lower cervical and upper thoracic spine (03-T3) after a laminoplasty has been performed. The Laminoplasty Plating System holds or buttresses the allograft in place in order to prevent expulsion of the allograft, or impingement of the spinal cord.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103284 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103284: Laminoplasy Plating System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103284
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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