510(k) · Cleared
ClearedHarrington Spine Instrumentation
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Orthopedic Equipment Co., Inc. · KWP Appliance, Fixation, Spinal Interlaminal
Cleared on Sep 27, 1978 after a 35-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 584 devices in its family, counting itself, has a Class I recall. 583 later devices descend from it.
- Decided
- Sep 27, 1978
- Review
- 35 days
- Class
- Class II
- Product code
- KWP
- Recalls
- None
- Predicates
- 0
583 later devices descend from it, 2 citing it directly. 1 of the 584 devices in this family, counting this one, has a Class I recall.
- This deviceK781443 Harrington Spine InstrumentationOrthopedic Equipment Co., Inc. · 1978
- Descendant · cites it directly · 582 of its ownK071668 Orthobiom Spinal SystemParadigm Spine · 2008
- Descendant · 2 generations on · 581 of its ownK091445 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2010
- Descendant · 3 generations on · 269 of its ownK110070 TSRH Spinal SystemMedtronic Sofamor Danck USA, Inc. · 2011
- Descendant · 3 generations on · 261 of its ownK111457 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2011
- Descendant · 3 generations on · 260 of its ownK113395 Revere 4.5 Stabilization SystemGlobus Medical, Inc. · 2012
Showing 5 of 583 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub5 generations on · 2021
Most influential descendants
Showing 5 of 583 · See all- K071668Orthobiom Spinal SystemParadigm Spine · 2008 · cites it directly582descendants
- K091445CD Horizon Spinal SystemMedtronic Sofamor Danek · 2010 · 2 generations on581descendants
- K110070TSRH Spinal SystemMedtronic Sofamor Danck USA, Inc. · 2011 · 3 generations on269descendants
- K111457CD Horizon Spinal SystemMedtronic Sofamor Danek · 2011 · 3 generations on261descendants
- K113395Revere 4.5 Stabilization SystemGlobus Medical, Inc. · 2012 · 3 generations on260descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K781443 | Harrington Spine Instrumentation | Orthopedic Equipment Co., Inc. | 1978 | — |
| +1 | K071668 | Orthobiom Spinal System | Paradigm Spine | 2008 | — |
| +2 | K091445 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2010 | — |
| +3 | K110070 | TSRH Spinal System | Medtronic Sofamor Danck USA, Inc. | 2011 | — |
| +3 | K111457 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2011 | — |
| +3 | K113395 | Revere 4.5 Stabilization System | Globus Medical, Inc. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 5 | 0 |
| 2012 | 15 | 0 |
| 2013 | 24 | 0 |
| 2014 | 32 | 0 |
| 2015 | 41 | 0 |
| 2016 | 35 | 0 |
| 2017 | 40 | 0 |
| 2018 | 39 | 0 |
| 2019 | 26 | 0 |
| 2020 | 36 | 0 |
| 2021 | 31 | 1 |
| 2022 | 40 | 0 |
| 2023 | 59 | 0 |
| 2024 | 59 | 0 |
| 2025 | 50 | 0 |
| 2026 | 48 | 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.
1 device in this family has a Class I recall. 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? (583)
See all 5832 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 5 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K071668 (Paradigm Spine, 2008) has gone furthest, with 582 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/K781443 · printed Nov 6, 2026
Cite this page
510(k) Report. “K781443: Harrington Spine Instrumentation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K781443
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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