510(k) · Cleared
ClearedPSS 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 Aug 21, 2007 as substantially equivalent to K980447 (DePuy Orthopaedics, Inc., 1998) and 2 other predicates after a 90-day review. Its family tree reaches back 3 generations to 2000. 39 later devices descend from it.
- Decided
- Aug 21, 2007
- Review
- 90 days
- Class
- Class II
- Product code
- MNI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K000319 (2000). 7 ancestors in all, the oldest K980447 (1998). 39 later devices descend from it, 10 citing it directly.
- Root · 3 generations backK000319 Ebi Xfix DFS SystemEbi, L.P. · 2000
- 2 generations backK020279 Forex Corporation, Optima, Spinal SystemForex Corp. · 2002 · Recalled
- 1 generation backK031585 U&I, Optima, Spinal SystemU&I Corp., America · 2003 · Recalled
- This deviceK071438 PSS SystemSpinal USA · 2007
- Descendant · cites it directly · 37 of its ownK090033 Modification to: PSS SystemSpinal USA · 2009
- Descendant · cites it directly · 36 of its ownK092128 Modification to: PSS SystemSpinal USA · 2009
- Descendant · cites it directly · 36 of its ownK073240 PSS SystemSpinal USA · 2008
- Descendant · cites it directly · 33 of its ownK121172 Reform Pedicle Screw SystemSpinal USA · 2012
- Descendant · cites it directly · 31 of its ownK131343 Reform Pedicle Screw SystemSpinal USA · 2013
Showing 5 of 39 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 39 · See all- K090033Modification to: PSS SystemSpinal USA · 2009 · cites it directly37descendants
- K092128Modification to: PSS SystemSpinal USA · 2009 · cites it directly36descendants
- K073240PSS SystemSpinal USA · 2008 · cites it directly36descendants
- K121172Reform Pedicle Screw SystemSpinal USA · 2012 · cites it directly33descendants
- K131343Reform Pedicle Screw SystemSpinal USA · 2013 · cites it directly31descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K000319 | Ebi Xfix DFS System | Ebi, L.P. | 2000 | — |
| −2 | K020279 | Forex Corporation, Optima, Spinal System | Forex Corp. | 2002 | 4 |
| −1 | K031585 | U&I, Optima, Spinal System | U&I Corp., America | 2003 | 5 |
| 0 (this device) | K071438 | PSS System | Spinal USA | 2007 | — |
| +1 | K090033 | Modification to: PSS System | Spinal USA | 2009 | — |
| +1 | K092128 | Modification to: PSS System | Spinal USA | 2009 | — |
| +1 | K073240 | PSS System | Spinal USA | 2008 | — |
| +1 | K121172 | Reform Pedicle Screw System | Spinal USA | 2012 | — |
| +1 | K131343 | Reform Pedicle Screw System | Spinal USA | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2020 | 3 | 0 |
| 2021 | 2 | 0 |
| 2022 | 3 | 0 |
| 2023 | 5 | 0 |
| 2024 | 4 | 0 |
| 2025 | 3 | 0 |
| 2026 | 5 | 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? (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 |
|---|---|---|---|
| * | K980447 | Depuy Motech Moss Miami Spinal SystemSummary page 1…Implant Constructs in a Vertebrectomy Model" of the PSS System demonstrates that the device is substantially equivalent to the Moss Miami Pedicle Fixation System (K980447), Optima Spine System (K031585), and the Xia Spinal System (K98425 1). DEPARTMENT OF HEALTH & HUMAN SERVIC… | 1998 |
| * | K031585 | U&I, Optima, Spinal SystemSummary page 1…rectomy Model" of the PSS System demonstrates that the device is substantially equivalent to the Moss Miami Pedicle Fixation System (K980447), Optima Spine System (K031585), and the Xia Spinal System (K98425 1). DEPARTMENT OF HEALTH & HUMAN SERVICES… | 2003 |
| * | K984251 | Xia Spine SystemSummary page 1…nstrates that the device is substantially equivalent to the Moss Miami Pedicle Fixation System (K980447), Optima Spine System (K031585), and the Xia Spinal System (K98425 1). DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service… | 1999 |
What descends from it? (39)
See all 3910 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K090033 | Modification to: PSS System | 2009 | 37 |
| K092128 | Modification to: PSS System | 2009 | 36 |
| K073240 | PSS System | 2008 | 36 |
| K121172 | Reform Pedicle Screw System | 2012 | 33 |
| K131343 | Reform Pedicle Screw System | 2013 | 31 |
| K130279 | Reform Pedicle Screw System | 2013 | 31 |
| K143248 | Reform Pedicle Screw System | 2014 | 30 |
| K150856 | Reform Pedicle Screw System | 2015 | 26 |
| K151422 | Reform Pedicle Screw System | 2015 | 19 |
| K122931 | S-Lok PSS System | 2012 | 0 |
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 7 years and passes through 4 companies; a new generation was cleared every 2.3 years on median.
- 2 of the 7 ancestors have a recall of any class.
- Of its descendants, K090033 (Spinal USA, 2009) has gone furthest, with 37 descendants of its own.
- 7 other devices also cite its predicate K980447.
How does its category compare?
All MNI devicesMNI Orthosis, Spinal Pedicle Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 PSS 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 the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis). The…
Read the full statement (147 words)
The PSS 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 the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis).
The PSS System is also intended for non-cervical pedicle screw fixation for the following indications: severe spondylolisthesis (grades 3 and 4 of 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 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/K071438 · printed Nov 6, 2026
Cite this page
510(k) Report. “K071438: 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/K071438
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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