510(k) · Cleared
ClearedSynthes Posterior Universal Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synthes Spine · MNI Orthosis, Spinal Pedicle Fixation
Cleared on Oct 21, 1998 after a 56-day review. The FDA summary names no predicate by number. 1 of the 227 devices in its family, counting itself, has a Class I recall. 226 later devices descend from it.
- Decided
- Oct 21, 1998
- Review
- 56 days
- Class
- Class II
- Product code
- MNI
- Recalls
- None
- Predicates
- 0
226 later devices descend from it, 3 citing it directly. 1 of the 227 devices in this family, counting this one, has a Class I recall.
- This deviceK982987 Synthes Posterior Universal Spinal SystemSynthes Spine · 1998
- Descendant · cites it directly · 146 of its ownK062136 Pass 2 Spinal SystemMedicrea · 2006
- Descendant · 2 generations on · 133 of its ownK110497 Pass LP Spinal SystemMedicrea International · 2011 · Recalled
- Descendant · 3 generations on · 132 of its ownK123138 Pass LP Spinal SystemMedicrea International · 2013
- Descendant · cites it directly · 93 of its ownK133350 Revere Stabilization SystemGlobus Medical, Inc. · 2014
- Descendant · 4 generations on · 84 of its ownK142798 PASS LP Spinal SystemMedicrea International SA · 2015
Showing 5 of 226 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub3 generations on · 2021
Most influential descendants
Showing 5 of 226 · See all- K062136Pass 2 Spinal SystemMedicrea · 2006 · cites it directly146descendants
- K110497Pass LP Spinal SystemMedicrea International · 2011 · 2 generations on133descendants
- K123138Pass LP Spinal SystemMedicrea International · 2013 · 3 generations on132descendants
- K133350Revere Stabilization SystemGlobus Medical, Inc. · 2014 · cites it directly93descendants
- K142798PASS LP Spinal SystemMedicrea International SA · 2015 · 4 generations on84descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K982987 | Synthes Posterior Universal Spinal System | Synthes Spine | 1998 | — |
| +1 | K062136 | Pass 2 Spinal System | Medicrea | 2006 | — |
| +2 | K110497 | Pass LP Spinal System | Medicrea International | 2011 | 1 |
| +3 | K123138 | Pass LP Spinal System | Medicrea International | 2013 | — |
| +1 | K133350 | Revere Stabilization System | Globus Medical, Inc. | 2014 | — |
| +4 | K142798 | PASS LP Spinal System | Medicrea International SA | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 2 | 0 |
| 2013 | 4 | 0 |
| 2014 | 3 | 0 |
| 2015 | 7 | 0 |
| 2016 | 10 | 0 |
| 2017 | 9 | 0 |
| 2018 | 9 | 0 |
| 2019 | 10 | 0 |
| 2020 | 10 | 0 |
| 2021 | 12 | 1 |
| 2022 | 22 | 0 |
| 2023 | 23 | 0 |
| 2024 | 33 | 0 |
| 2025 | 36 | 0 |
| 2026 | 34 | 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? (226)
See all 2263 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 · 3 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K062136 (Medicrea, 2006) has gone furthest, with 146 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 < a postertor pedicle screw fixativn system, the Synthes Posterior Universal Spinal System devices are inteuded to provide immobilization and stabilization ot spinal segments in skeletally maturc paticnts as an adjunct to fusion in the treatment of the followiug acute and chronic inetabilities or deformities of the thoracic, lubar, and sacral spine: degenerative spondylolisthesis with objectlve cvidence of ncurologic impairment, fracture…
Read the full statement (220 words)
When used < a postertor pedicle screw fixativn system, the Synthes Posterior Universal Spinal System devices are inteuded to provide immobilization and stabilization ot spinal segments in skeletally maturc paticnts as an adjunct to fusion in the treatment of the followiug acute and chronic inetabilities or deformities of the thoracic, lubar, and sacral spine: degenerative spondylolisthesis with objectlve cvidence of ncurologic impairment, fracture, dislocation. scoliosls, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
In addition, the Synthes Posterior Universal Spinal Systeu is intended for treatment of severe spondylolisthesis (Grade 3 and 4) of the L, - S, vertebra in skeletally marure patients recelving fusion by autogenous bone graft having implants attached to the lumbar and sucial spine with removal of the implants after the attainment of a solid fusiun. The levels of pedicle serew fixation for these patients are L3-52.
When uced 2s 2 posterior nan-pedicle screw fixation system, Syuties Posterior Universal Spinal System devices are intended for scolivtic, lurdotic, or kyphotic deformities (such as scoliasic. Schuermann’s discusc), degenerative dise disease (back pain of diseogenic origin with degeneration of the disc confirmed by hictory and radiographic studies), and fractures of the pustciior tharacolumbar spine. In addition, when used with the 3.5mm / 6.0mm parallel conncctor, the Synthes Posterior Universal Spinal System can be liitked to the Posterior Cervical/Thoracic Hook/Rod 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/K982987 · printed Nov 5, 2026
Cite this page
510(k) Report. “K982987: Synthes Posterior Universal Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K982987
Report an extraction error
Are you the manufacturer?
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