510(k) · Cleared
ClearedS-Lok PSS System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spinal USA · MNI Orthosis, Spinal Pedicle Fixation
Cleared on Nov 20, 2012 as substantially equivalent to K092128 (Spinal USA, 2009) and 4 other predicates after a 57-day review. Its family tree reaches back 6 generations to 2000.
- Decided
- Nov 20, 2012
- Review
- 57 days
- Class
- Class II
- Product code
- MNI
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 6 generations to K000319 (2000). 12 ancestors in all, the oldest K980447 (1998). No later device cites it as a predicate yet.
- Root · 6 generations backK000319 Ebi Xfix DFS SystemEbi, L.P. · 2000
- 5 generations backK020279 Forex Corporation, Optima, Spinal SystemForex Corp. · 2002 · Recalled
- 4 generations backK031585 U&I, Optima, Spinal SystemU&I Corp., America · 2003 · Recalled
- 3 generations backK071438 PSS SystemSpinal USA · 2007
- 2 generations backK090033 Modification to: PSS SystemSpinal USA · 2009
- 1 generation backK092128 Modification to: PSS SystemSpinal USA · 2009
- This deviceK122931 S-Lok PSS SystemSpinal USA · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K000319 | Ebi Xfix DFS System | Ebi, L.P. | 2000 | — |
| −5 | K020279 | Forex Corporation, Optima, Spinal System | Forex Corp. | 2002 | 4 |
| −4 | K031585 | U&I, Optima, Spinal System | U&I Corp., America | 2003 | 5 |
| −3 | K071438 | PSS System | Spinal USA | 2007 | — |
| −2 | K090033 | Modification to: PSS System | Spinal USA | 2009 | — |
| −1 | K092128 | Modification to: PSS System | Spinal USA | 2009 | — |
| 0 (this device) | K122931 | S-Lok PSS System | Spinal USA | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 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 MNI? 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? (5)
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 |
|---|---|---|---|
| * | K092128 | Modification to: PSS SystemSummary page 1…MINH CFR section: 21 CFR section 888.3070 Device panel: Orthopedic Legally Marketed PSS System - K<092128 / K090033 /K073240 /K071438 Predicate Device: Nu Vasive SpheRx PPS System - K<090981 Subm… | 2009 |
| * | K090033 | Modification to: PSS SystemSummary page 1…MINH CFR section: 21 CFR section 888.3070 Device panel: Orthopedic Legally Marketed PSS System - K<092128 / K090033 /K073240 /K071438 Predicate Device: Nu Vasive SpheRx PPS System - K<090981 Submitter: Spi… | 2009 |
| * | K073240 | PSS SystemSummary page 1…CFR section: 21 CFR section 888.3070 Device panel: Orthopedic Legally Marketed PSS System - K<092128 / K090033 /K073240 /K071438 Predicate Device: Nu Vasive SpheRx PPS System - K<090981 Submitter: Spinal USA… | 2008 |
| * | K071438 | PSS SystemSummary page 1…CFR section: 21 CFR section 888.3070 Device panel: Orthopedic Legally Marketed PSS System - K<092128 / K090033 /K073240 /K071438 Predicate Device: Nu Vasive SpheRx PPS System - K<090981 Submitter: Spinal USA… | 2007 |
| * | K090981 | Modification to: Nuvasive Spherx SystemSummary page 1…ce panel: Orthopedic Legally Marketed PSS System - K<092128 / K090033 /K073240 /K071438 Predicate Device: Nu Vasive SpheRx PPS System - K<090981 Submitter: Spinal USA 2050 Executive Drive… | 2009 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 12 years and passes through 4 companies; a new generation was cleared every 2.3 years on median.
- 2 of the 12 ancestors have a recall of any class.
- 7 other devices also cite its predicate K092128.
How does its category compare?
All MNI devicesMNI Orthosis, Spinal Pedicle Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
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?
The S-LOK TM P55 System is 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 thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion…
Read the full statement (149 words)
The S-LOK TM P55 System is 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 thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis).
The S-LOKW PS5 System is also intended for non-cervical pedicle screw fixation for the following indications: severe spondylolisthesis (grades 3 and 4) of the LS-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 attainment of a solid fusion. It is also intended for the following indications: trauma (i.e. fracture or dislocation); spinal stenosis; curvatures (i.e. scoliosis, kyphosis, and/or lordosis); spinal tumor; pseudoarthrosis; and failed previous fusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122931 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122931: S-Lok PSS System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122931
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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