510(k) · Cleared
ClearedSmall Stature Uss
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synthes (Usa) · MNI Orthosis, Spinal Pedicle Fixation
Cleared on Oct 17, 2000 after a 316-day review. The FDA summary names no predicate by number. 1 of the 943 devices in its family, counting itself, has a Class I recall. 942 later devices descend from it.
- Decided
- Oct 17, 2000
- Review
- 316 days
- Class
- Class II
- Product code
- MNI
- Recalls
- None
- Predicates
- 0
942 later devices descend from it, 13 citing it directly. 1 of the 943 devices in this family, counting this one, has a Class I recall.
- This deviceK994121 Small Stature UssSynthes (Usa) · 2000
- Descendant · cites it directly · 582 of its ownK071668 Orthobiom Spinal SystemParadigm Spine · 2008
- Descendant · cites it directly · 581 of its ownK091445 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2010
- Descendant · cites it directly · 472 of its ownK081568 Antegra-TSynthes Spine Co.Lp · 2008
- Descendant · 2 generations on · 469 of its ownK121815 Nuvasive Sage Lateral Plate SystemNuvasive, Inc. · 2012
- Descendant · 3 generations on · 466 of its ownK131723 Coroent Single Tab SystemNuvasive, Inc. · 2013
Showing 5 of 942 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub4 generations on · 2021
Most influential descendants
Showing 5 of 942 · See all- K071668Orthobiom Spinal SystemParadigm Spine · 2008 · cites it directly582descendants
- K091445CD Horizon Spinal SystemMedtronic Sofamor Danek · 2010 · cites it directly581descendants
- K081568Antegra-TSynthes Spine Co.Lp · 2008 · cites it directly472descendants
- K121815Nuvasive Sage Lateral Plate SystemNuvasive, Inc. · 2012 · 2 generations on469descendants
- K131723Coroent Single Tab SystemNuvasive, Inc. · 2013 · 3 generations on466descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K994121 | Small Stature Uss | Synthes (Usa) | 2000 | — |
| +1 | K071668 | Orthobiom Spinal System | Paradigm Spine | 2008 | — |
| +1 | K091445 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2010 | — |
| +1 | K081568 | Antegra-T | Synthes Spine Co.Lp | 2008 | — |
| +2 | K121815 | Nuvasive Sage Lateral Plate System | Nuvasive, Inc. | 2012 | — |
| +3 | K131723 | Coroent Single Tab System | Nuvasive, Inc. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 3 | 0 |
| 2010 | 2 | 0 |
| 2011 | 5 | 0 |
| 2012 | 16 | 0 |
| 2013 | 26 | 0 |
| 2014 | 34 | 0 |
| 2015 | 42 | 0 |
| 2016 | 47 | 0 |
| 2017 | 57 | 0 |
| 2018 | 58 | 0 |
| 2019 | 48 | 0 |
| 2020 | 75 | 0 |
| 2021 | 70 | 1 |
| 2022 | 84 | 0 |
| 2023 | 106 | 0 |
| 2024 | 109 | 0 |
| 2025 | 88 | 0 |
| 2026 | 72 | 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.
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?
The FDA summary names no predicate by number.
What descends from it? (942)
See all 94213 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K071668 | Orthobiom Spinal System | 2008 | 582 |
| K091445 | CD Horizon Spinal System | 2010 | 581 |
| K081568 | Antegra-T | 2008 | 472 |
| K113395 | Revere 4.5 Stabilization System | 2012 | 260 |
| K113666 | Xia 3 Spinal System | 2012 | 251 |
| K120291 | OP Spine System | 2012 | 138 |
| K121630 | Range Spinal System | 2012 | 127 |
| K121342 | Xia 4.5 Spinal System | 2012 | 88 |
| K130932 | Firebird Spinal Fixation System | 2013 | 81 |
| K110348 | Universal Clamp Spinal Fixation System | 2011 | 44 |
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 · 4 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 MNI devicesMNI Orthosis, Spinal Pedicle Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MNI
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · MNI
168in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MNI
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MNI
80in 2025
MAUDE reports naming product code MNI, 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 | 20 | 82 | 26 | 83 |
| 2008 | 23 | 64 | 8 | 108 |
| 2009 | 18 | 86 | 3 | 138 |
| 2010 | 16 | 74 | 1 | 126 |
| 2011 | 17 | 111 | 0 | 146 |
| 2012 | 19 | 75 | 1 | 200 |
| 2013 | 14 | 77 | 4 | 824 |
| 2014 | 6 | 104 | 0 | 301 |
| 2015 | 12 | 54 | 1 | 260 |
| 2016 | 7 | 168 | 0 | 117 |
| 2017 | 1 | — | 0 | 247 |
| 2018 | 0 | — | 1 | 134 |
| 2019 | 0 | — | 0 | 188 |
| 2020 | 0 | — | 0 | 115 |
| 2021 | 0 | — | 0 | 270 |
| 2022 | 0 | — | 0 | 214 |
| 2023 | 0 | — | 0 | 122 |
| 2024 | 0 | — | 0 | 114 |
| 2025 | 0 | — | 0 | 80 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
When used as a posterior pedicle screw fixation system, the Synthes Small. Stature USS s intended to provide immobilization and stabilization of spinal segments in skeletally mature patients (including smail stature) as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the theracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture…
Read the full statement (297 words)
When used as a posterior pedicle screw fixation system, the Synthes Small. Stature USS s intended to provide immobilization and stabilization of spinal segments in skeletally mature patients (including smail stature) as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the theracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliasis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrasis).
In addition, the Synthes Small Stature USS is intended for treatment of severe spondylofisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients (including smalil stature) and pediatric patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine with removal of the implants after the attainment of a solid Tusian. The levels of pedicle screw fixation for these patients are L.3-82.
When used as a posterior non-pedicle screw fixation system in skeletally mature patients (including small stature) and pediatric patients, the Synthes Smail Stature USS is intended for scoliotic, lordotic, or kyphotic deformities (such as scoliosis, Schuermann's disease), degenerative disc disease (back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), and fractures of the posterior thoracolumbar sgine.
The anterior components of the Synthes Small Stature USS when used in skeletally mature patients (Including small stature) and pediatric patients are intended for anterolateral screw and/or staple fixation for the correction of anterolateral lordotic deformities for the spine, lumbar gcoliosis, pseudoarthrosis, and fracture or dislacation of the thoracolumbar spine-{levels 78-L.5),
In addition, when used with 3.5/5.0mm parallel connectors, the Synthes Small Stature USS can be linked to the CerviFix System. When used with 5.0/6.0mm parallel connectors, the Synthes Small Stature USS c¢an be linked to the Universal Spinal System
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/K994121 · printed Nov 4, 2026
Cite this page
510(k) Report. “K994121: Small Stature Uss.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K994121
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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