510(k) · Cleared
ClearedBWM Spine System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Howmedica Corp. · KWP Appliance, Fixation, Spinal Interlaminal
Cleared on Sep 8, 1998 after a 53-day review. The FDA summary names its predicate without a number. 206 later devices descend from it.
- Decided
- Sep 8, 1998
- Review
- 53 days
- Class
- Class II
- Product code
- KWP
- Recalls
- None
- Predicates
- 0
206 later devices descend from it, 2 citing it directly.
- This deviceK982494 BWM Spine SystemHowmedica Corp. · 1998
- Descendant · cites it directly · 205 of its ownK013688 Modification to Xia Spinal SystemHowmedica Osteonics Corp. · 2001
- Descendant · 2 generations on · 202 of its ownK052181 Modification to Xia Spinal SystemStryker Spine · 2005
- Descendant · 3 generations on · 201 of its ownK070631 Device Modification to Radius Spinal SystemStryker Spine · 2007
- Descendant · 4 generations on · 200 of its ownK082608 Radius Spinal System, Vitallium Rod #486613601Stryker Spine · 2008
- Descendant · 5 generations on · 169 of its ownK091291 Xia 3 Spinal System, Uniplanner/Reduction Screws & Vitallium RodStryker Spine · 2009
Showing 5 of 206 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 206 · See all- K013688Modification to Xia Spinal SystemHowmedica Osteonics Corp. · 2001 · cites it directly205descendants
- K052181Modification to Xia Spinal SystemStryker Spine · 2005 · 2 generations on202descendants
- K070631Device Modification to Radius Spinal SystemStryker Spine · 2007 · 3 generations on201descendants
- K082608Radius Spinal System, Vitallium Rod #486613601Stryker Spine · 2008 · 4 generations on200descendants
- K091291Xia 3 Spinal System, Uniplanner/Reduction Screws & Vitallium RodStryker Spine · 2009 · 5 generations on169descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K982494 | BWM Spine System | Howmedica Corp. | 1998 | — |
| +1 | K013688 | Modification to Xia Spinal System | Howmedica Osteonics Corp. | 2001 | — |
| +2 | K052181 | Modification to Xia Spinal System | Stryker Spine | 2005 | — |
| +3 | K070631 | Device Modification to Radius Spinal System | Stryker Spine | 2007 | — |
| +4 | K082608 | Radius Spinal System, Vitallium Rod #486613601 | Stryker Spine | 2008 | — |
| +5 | K091291 | Xia 3 Spinal System, Uniplanner/Reduction Screws & Vitallium Rod | Stryker Spine | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 3 | 0 |
| 2010 | 2 | 0 |
| 2011 | 3 | 0 |
| 2012 | 4 | 0 |
| 2013 | 5 | 0 |
| 2014 | 6 | 0 |
| 2015 | 9 | 0 |
| 2016 | 4 | 0 |
| 2017 | 12 | 0 |
| 2018 | 14 | 0 |
| 2019 | 11 | 0 |
| 2020 | 17 | 0 |
| 2021 | 7 | 0 |
| 2022 | 14 | 0 |
| 2023 | 26 | 0 |
| 2024 | 25 | 0 |
| 2025 | 18 | 0 |
| 2026 | 20 | 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 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? (3)
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 |
|---|---|---|---|
| * | — | Synthes® Spine’s Universal Spinal System (USS) Named without a submission number | |
| * | — | Isola® Spinal System by Acromed® Named without a submission number | |
| * | — | DePuy Motech MOSS Miami Spinal System Named without a submission number |
What descends from it? (206)
See all 2062 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, K013688 (Howmedica Osteonics Corp., 2001) has gone furthest, with 205 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 | — |
What is it indicated for?
The BWM Spine System is intended for use in the noncervical spine. When used as a pedicle screw fixation system, it is intended for patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar - first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine; and (d) who are having the device removed after the…
Read the full statement (162 words)
The BWM Spine System is intended for use in the noncervical spine.
When used as a pedicle screw fixation system, it is intended for patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar - first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine; and (d) who are having the device removed after the development of a solid fusion mass. Pedicle screw fixation is limited to L3 to S1 or the ilium.
When used as an anterior screw fixation system or a posterior hook and sacral/iliac screw fixation system, the system is indicated for patients with degenerative disc disease which is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, fracture, spinal stenosis, spinal deformities such as scoliosis, kyphosis, lordosis, tumor, pseudoarthrosis or revision of failed fusion attempts.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K982494 · printed Nov 6, 2026
Cite this page
510(k) Report. “K982494: BWM Spine System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K982494
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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