510(k) · Cleared
ClearedTSRH H/M Hook, Eyebolt/Lock Nut Assem., Spinal Rod
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Warsaw Orthopedic, Inc. · KWP Appliance, Fixation, Spinal Interlaminal
Cleared on Feb 18, 1988 after a 30-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 9 later devices descend from it.
- Decided
- Feb 18, 1988
- Review
- 30 days
- Class
- Class II
- Product code
- KWP
- Recalls
- None
- Predicates
- 0
9 later devices descend from it, 3 citing it directly.
- This deviceK880215 TSRH H/M Hook, Eyebolt/Lock Nut Assem., Spinal RodWarsaw Orthopedic, Inc. · 1988
- Descendant · cites it directly · 8 of its ownK081978 Reliance Spinal Screw SystemReliance Medical Systems, LLC · 2009
- Descendant · cites it directly · 7 of its ownK101112 Reliance Spinal Screw SystemReliance Medical Systems · 2010
- Descendant · 2 generations on · 5 of its ownK123521 Reliance Spinal Screw SystemReliance Medical Systems, LLC · 2013
- Descendant · cites it directly · 5 of its ownK110896 Reliance Spinal Screw SystemReliance Medical Systems, LLC · 2012
- Descendant · 2 generations on · 4 of its ownK152131 Reliance Spinal Screw SystemReliance Medical Systems, LLC · 2015
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K081978Reliance Spinal Screw SystemReliance Medical Systems, LLC · 2009 · cites it directly8descendants
- K101112Reliance Spinal Screw SystemReliance Medical Systems · 2010 · cites it directly7descendants
- K123521Reliance Spinal Screw SystemReliance Medical Systems, LLC · 2013 · 2 generations on5descendants
- K110896Reliance Spinal Screw SystemReliance Medical Systems, LLC · 2012 · cites it directly5descendants
- K152131Reliance Spinal Screw SystemReliance Medical Systems, LLC · 2015 · 2 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K880215 | TSRH H/M Hook, Eyebolt/Lock Nut Assem., Spinal Rod | Warsaw Orthopedic, Inc. | 1988 | — |
| +1 | K081978 | Reliance Spinal Screw System | Reliance Medical Systems, LLC | 2009 | — |
| +1 | K101112 | Reliance Spinal Screw System | Reliance Medical Systems | 2010 | — |
| +2 | K123521 | Reliance Spinal Screw System | Reliance Medical Systems, LLC | 2013 | — |
| +1 | K110896 | Reliance Spinal Screw System | Reliance Medical Systems, LLC | 2012 | — |
| +2 | K152131 | Reliance Spinal Screw System | Reliance Medical Systems, LLC | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KWP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (9)
3 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K081978 (Reliance Medical Systems, LLC, 2009) has gone furthest, with 8 descendants of its own.
How does its category compare?
All KWP devicesKWP Appliance, Fixation, Spinal Interlaminal: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KWP
9in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · KWP
113in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWP
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWP
494in 2025
MAUDE reports naming product code KWP, 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 | 14 | 96 | 2 | 210 |
| 2008 | 13 | 50 | 1 | 594 |
| 2009 | 12 | 89 | 23 | 682 |
| 2010 | 14 | 186 | 2 | 474 |
| 2011 | 12 | 67 | 6 | 792 |
| 2012 | 18 | 112 | 1 | 918 |
| 2013 | 12 | 99 | 3 | 1,090 |
| 2014 | 13 | 138 | 0 | 1,022 |
| 2015 | 9 | 113 | 1 | 1,348 |
| 2016 | 0 | — | 3 | 1,379 |
| 2017 | 0 | — | 0 | 864 |
| 2018 | 0 | — | 1 | 657 |
| 2019 | 0 | — | 2 | 518 |
| 2020 | 0 | — | 0 | 796 |
| 2021 | 0 | — | 0 | 525 |
| 2022 | 0 | — | 2 | 335 |
| 2023 | 0 | — | 0 | 332 |
| 2024 | 0 | — | 0 | 436 |
| 2025 | 0 | — | 0 | 494 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K880215 · printed Nov 5, 2026
Cite this page
510(k) Report. “K880215: TSRH H/M Hook, Eyebolt/Lock Nut Assem., Spinal Rod.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K880215
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026