510(k) · Cleared
ClearedSofamor Orfil Spine Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sofamor Co. · KWP Appliance, Fixation, Spinal Interlaminal
Cleared on Jun 2, 1994 after a 288-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 69 later devices descend from it.
- Decided
- Jun 2, 1994
- Review
- 288 days
- Class
- Class II
- Product code
- KWP
- Recalls
- None
- Predicates
- 0
69 later devices descend from it, 1 citing it directly.
- This deviceK934007 Sofamor Orfil Spine Fixation SystemSofamor Co. · 1994
- Descendant · cites it directly · 68 of its ownK020426 MSD Wire SystemMedtronic Sofamor Danek, Inc. · 2002
- Descendant · 2 generations on · 67 of its ownK072605 Malibu Spinal SystemSeaspine, Inc. · 2007
- Descendant · 3 generations on · 62 of its ownK122571 Malibu Spinal System with the Daytona Deformity SystemSeaspine, Inc. · 2012
- Descendant · 3 generations on · 60 of its ownK160902 Mariner Pedicle Screw SystemSeaSpine Orthopedics Corporation · 2016
- Descendant · 3 generations on · 56 of its ownK173882 SeaSpine Mariner Pedicle Screw SystemSeaSpine Orthopedics Corporation · 2018 · Recalled
Showing 5 of 69 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 69 · See all- K020426MSD Wire SystemMedtronic Sofamor Danek, Inc. · 2002 · cites it directly68descendants
- K072605Malibu Spinal SystemSeaspine, Inc. · 2007 · 2 generations on67descendants
- K122571Malibu Spinal System with the Daytona Deformity SystemSeaspine, Inc. · 2012 · 3 generations on62descendants
- K160902Mariner Pedicle Screw SystemSeaSpine Orthopedics Corporation · 2016 · 3 generations on60descendants
- K173882SeaSpine Mariner Pedicle Screw SystemSeaSpine Orthopedics Corporation · 2018 · 3 generations on56descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K934007 | Sofamor Orfil Spine Fixation System | Sofamor Co. | 1994 | — |
| +1 | K020426 | MSD Wire System | Medtronic Sofamor Danek, Inc. | 2002 | — |
| +2 | K072605 | Malibu Spinal System | Seaspine, Inc. | 2007 | — |
| +3 | K122571 | Malibu Spinal System with the Daytona Deformity System | Seaspine, Inc. | 2012 | — |
| +3 | K160902 | Mariner Pedicle Screw System | SeaSpine Orthopedics Corporation | 2016 | — |
| +3 | K173882 | SeaSpine Mariner Pedicle Screw System | SeaSpine Orthopedics Corporation | 2018 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2007 | 1 | 0 |
| 2012 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 3 | 0 |
| 2019 | 2 | 0 |
| 2020 | 3 | 0 |
| 2021 | 3 | 0 |
| 2022 | 5 | 0 |
| 2023 | 9 | 0 |
| 2024 | 9 | 0 |
| 2025 | 14 | 0 |
| 2026 | 15 | 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (69)
See all 691 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K020426 | MSD Wire System | 2002 | 68 |
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, K020426 (Medtronic Sofamor Danek, Inc., 2002) has gone furthest, with 68 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/K934007 · printed Nov 5, 2026
Cite this page
510(k) Report. “K934007: Sofamor Orfil Spine Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K934007
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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