510(k) · Cleared
Recalled · 2009Stryker Spine Maps System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Howmedica Osteonics · MNH Orthosis, Spondylolisthesis Spinal Fixation
Cleared on Dec 10, 2003 after an 89-day review. The FDA summary names no predicate by number. 113 later devices descend from it. It has been recalled once.
- Decided
- Dec 10, 2003
- Review
- 89 days
- Class
- Class II
- Product code
- MNH
- Recalls
- 1
- Predicates
- 0
113 later devices descend from it, 3 citing it directly.
- This deviceK032855 Stryker Spine Maps SystemHowmedica Osteonics · 2003
- Descendant · cites it directly · 112 of its ownK052971 Stryker Spine Trio Spinal Fixation SystemStryker Spine · 2005 · Recalled
- Descendant · cites it directly · 88 of its ownK062698 Trio + Spinal SystemStryker Spine · 2006 · Recalled
- Descendant · cites it directly · 87 of its ownK070368 Trio Plate System, Trio Spinal Fixation System, Trio+ Spinal SystemStryker Corp. · 2007
- Descendant · 2 generations on · 86 of its ownK100737 Modification to: Trio+Spinal Fixation SystemStryker Spine · 2010
- Descendant · 2 generations on · 85 of its ownK103292 Trio Trauma Spinal SystemStryker Corporation · 2011
Showing 5 of 113 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 113 · See all- K052971Stryker Spine Trio Spinal Fixation SystemStryker Spine · 2005 · cites it directly112descendants
- K062698Trio + Spinal SystemStryker Spine · 2006 · cites it directly88descendants
- K070368Trio Plate System, Trio Spinal Fixation System, Trio+ Spinal SystemStryker Corp. · 2007 · cites it directly87descendants
- K100737Modification to: Trio+Spinal Fixation SystemStryker Spine · 2010 · 2 generations on86descendants
- K103292Trio Trauma Spinal SystemStryker Corporation · 2011 · 2 generations on85descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K032855 | Stryker Spine Maps System | Howmedica Osteonics | 2003 | — |
| +1 | K052971 | Stryker Spine Trio Spinal Fixation System | Stryker Spine | 2005 | 2 |
| +1 | K062698 | Trio + Spinal System | Stryker Spine | 2006 | 2 |
| +1 | K070368 | Trio Plate System, Trio Spinal Fixation System, Trio+ Spinal System | Stryker Corp. | 2007 | — |
| +2 | K100737 | Modification to: Trio+Spinal Fixation System | Stryker Spine | 2010 | — |
| +2 | K103292 | Trio Trauma Spinal System | Stryker Corporation | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 4 | 0 |
| 2016 | 3 | 0 |
| 2017 | 5 | 0 |
| 2018 | 9 | 0 |
| 2019 | 5 | 0 |
| 2020 | 9 | 0 |
| 2021 | 3 | 0 |
| 2022 | 7 | 0 |
| 2023 | 16 | 0 |
| 2024 | 17 | 0 |
| 2025 | 10 | 0 |
| 2026 | 11 | 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 MNH? 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?
The FDA summary names no predicate by number.
What descends from it? (113)
See all 1133 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 1, 2009 | Not classified | Z-1886-2009 | Other | The Trio 3.5MM Hex socket has been reported to break under high stresses. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K052971 (Stryker Spine, 2005) has gone furthest, with 112 descendants of its own.
How does its category compare?
All MNH devicesMNH Orthosis, Spondylolisthesis Spinal Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MNH
8in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · MNH
93in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MNH
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MNH
89in 2025
MAUDE reports naming product code MNH, 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 | 5 | 123 | 0 | 18 |
| 2008 | 13 | 65 | 0 | 30 |
| 2009 | 13 | 151 | 7 | 45 |
| 2010 | 10 | 106 | 0 | 59 |
| 2011 | 17 | 171 | 0 | 107 |
| 2012 | 7 | 93 | 1 | 433 |
| 2013 | 10 | 124 | 1 | 464 |
| 2014 | 12 | 140 | 0 | 286 |
| 2015 | 10 | 99 | 0 | 152 |
| 2016 | 8 | 93 | 1 | 216 |
| 2017 | 0 | — | 0 | 174 |
| 2018 | 0 | — | 0 | 129 |
| 2019 | 0 | — | 0 | 403 |
| 2020 | 0 | — | 0 | 432 |
| 2021 | 0 | — | 0 | 531 |
| 2022 | 0 | — | 0 | 265 |
| 2023 | 0 | — | 0 | 121 |
| 2024 | 0 | — | 0 | 302 |
| 2025 | 0 | — | 0 | 89 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Stryker Spine MAPS System is a pedicle screw system intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed…
Read the full statement (208 words)
The Stryker Spine MAPS System is a pedicle screw system intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
The Stryker Spine MAPS System is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grades 3 and 4) at the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the development of a solid fusion mass.
The Stryker Spine MAPS System is also a sacral/iliac screw fixation system indicated for degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, kyphosis and/or lordosis), tumor, pseudoarthrosis and revision of failed fusion attempts.
The Stryker Spine MAPS System is also intended to be used in conjunction with the OSS/Diapason Rods, Opus Spinal System Rods and the Multi-Axis Cross Connectors.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032855 · printed Nov 4, 2026
Cite this page
510(k) Report. “K032855: Stryker Spine Maps System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K032855
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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