510(k) · Cleared
ClearedReform Pedicle Screw 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 8, 2012 as substantially equivalent to K071438 (Spinal USA, 2007) and 5 other predicates after a 113-day review. Its family tree reaches back 13 generations to 1985. 33 later devices descend from it.
- Decided
- Aug 8, 2012
- Review
- 113 days
- Class
- Class II
- Product code
- MNI
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 13 generations to K853033 (1985). 96 ancestors in all, the oldest K841189 (1984). 33 later devices descend from it, 5 citing it directly.
- Root · 13 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 9 generations between
- 3 generations backK063741 Expedium Spine SystemDepuy Spine, Inc. · 2007
- 2 generations backK080313 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2008
- 1 generation backK111571 Viper SystemsJohnson & Johnson · 2011
- This deviceK121172 Reform Pedicle Screw SystemSpinal USA · 2012
- Descendant · cites it directly · 31 of its ownK131343 Reform Pedicle Screw SystemSpinal USA · 2013
- Descendant · cites it directly · 31 of its ownK130279 Reform Pedicle Screw SystemSpinal USA · 2013
- Descendant · cites it directly · 30 of its ownK143248 Reform Pedicle Screw SystemPrecision Spine, Inc. · 2014
- Descendant · cites it directly · 26 of its ownK150856 Reform Pedicle Screw SystemPrecision Spine, Inc. · 2015
- Descendant · 2 generations on · 21 of its ownK173130 Reform® Midline Cortical Screw SystemPrecision Spine, Inc. · 2017
Show all 13 generations
- Root · 13 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 12 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
- 11 generations backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
- 10 generations backK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
- 9 generations backK013222 Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed · 2001
- 8 generations backK022190 Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2002
- 7 generations backK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
- 6 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
- 5 generations backK062174 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- 4 generations backK063156 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- 3 generations backK063741 Expedium Spine SystemDepuy Spine, Inc. · 2007
- 2 generations backK080313 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2008
- 1 generation backK111571 Viper SystemsJohnson & Johnson · 2011
- This deviceK121172 Reform Pedicle Screw SystemSpinal USA · 2012
Showing 5 of 33 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 33 · See all- K131343Reform Pedicle Screw SystemSpinal USA · 2013 · cites it directly31descendants
- K130279Reform Pedicle Screw SystemSpinal USA · 2013 · cites it directly31descendants
- K143248Reform Pedicle Screw SystemPrecision Spine, Inc. · 2014 · cites it directly30descendants
- K150856Reform Pedicle Screw SystemPrecision Spine, Inc. · 2015 · cites it directly26descendants
- K173130Reform® Midline Cortical Screw SystemPrecision Spine, Inc. · 2017 · 2 generations on21descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K853033 | Hartshill Rect & Wires, Spinal Fixation System | A.W. Showell (Surgicraft), Ltd. | 1985 | — |
| −12 | K965221 | Ransford Cervical Fixation System | Surgicraft, Ltd. | 1997 | — |
| −11 | K982322 | Synthes Spine Occipital-Cervical Plate/Rod and Hook System | Synthes (Usa) | 1998 | — |
| −10 | K002733 | Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2000 | — |
| −9 | K013222 | Summit Occipito-Cervico- Thoracic (Oct) Spinal System | Depuyacromed | 2001 | — |
| −8 | K022190 | Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2002 | — |
| −7 | K030103 | Summit Oct Spinal System Minipolyaxial Screws | Depuyacromed | 2003 | — |
| −6 | K041203 | Summit Oct Spinal System | Depuy Spine, Inc. | 2004 | — |
| −5 | K062174 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2006 | — |
| −4 | K063156 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2006 | — |
| −3 | K063741 | Expedium Spine System | Depuy Spine, Inc. | 2007 | — |
| −2 | K080313 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2008 | — |
| −1 | K111571 | Viper Systems | Johnson & Johnson | 2011 | — |
| 0 (this device) | K121172 | Reform Pedicle Screw System | Spinal USA | 2012 | — |
| +1 | K131343 | Reform Pedicle Screw System | Spinal USA | 2013 | — |
| +1 | K130279 | Reform Pedicle Screw System | Spinal USA | 2013 | — |
| +1 | K143248 | Reform Pedicle Screw System | Precision Spine, Inc. | 2014 | — |
| +1 | K150856 | Reform Pedicle Screw System | Precision Spine, Inc. | 2015 | — |
| +2 | K173130 | Reform® Midline Cortical Screw System | Precision Spine, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 2 | 0 |
| 1998 | 7 | 0 |
| 1999 | 8 | 0 |
| 2000 | 9 | 0 |
| 2001 | 10 | 0 |
| 2002 | 6 | 0 |
| 2003 | 6 | 0 |
| 2004 | 13 | 0 |
| 2005 | 7 | 0 |
| 2006 | 2 | 0 |
| 2007 | 4 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 2 | 0 |
| 2014 | 1 | 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? (7)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K071438 | PSS SystemSummary page 1…MNH CFR section: 21 CFR section 888.3070 Device panel: Orthopedic PSS System (K071438 / K073240 / K0900331K092 128) Legally Marketed Viper Spine System (K061520 / K1 11571) Predicate De… | 2007 |
| * | K073240 | PSS SystemSummary page 1…MNH CFR section: 21 CFR section 888.3070 Device panel: Orthopedic PSS System (K071438 / K073240 / K0900331K092 128) Legally Marketed Viper Spine System (K061520 / K1 11571) Predicate Device: S-LO… | 2008 |
| * | K090033 | Modification to: PSS SystemSummary page 1…CFR section: 21 CFR section 888.3070 Device panel: Orthopedic PSS System (K071438 / K073240 / K0900331K092 128) Legally Marketed Viper Spine System (K061520 / K1 11571) Predicate Device: S-LOK (K09~2,2… | 2009 |
| * | K092128 | Modification to: PSS SystemSummary page 1…CFR section: 21 CFR section 888.3070 Device panel: Orthopedic PSS System (K071438 / K073240 / K0900331K092 128) Legally Marketed Viper Spine System (K061520 / K1 11571) Predicate Device: S-LOK (K09~2,28)… | 2009 |
| * | K061520 | Viper Spine SystemSummary page 1…Device panel: Orthopedic PSS System (K071438 / K073240 / K0900331K092 128) Legally Marketed Viper Spine System (K061520 / K1 11571) Predicate Device: S-LOK (K09~2,28) Submitter: Spinal USA… | 2006 |
| * | K111571 | Viper SystemsSummary page 1…Device panel: Orthopedic PSS System (K071438 / K073240 / K0900331K092 128) Legally Marketed Viper Spine System (K061520 / K1 11571) Predicate Device: S-LOK (K09~2,28) Submitter: Spinal USA… | 2011 |
| Kept off the family tree | K090228 | FDA’s K090228 is Roc Lumbar Plating System Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2009 |
What descends from it? (33)
See all 335 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)
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 27 years and passes through 7 companies; a new generation was cleared every 1.3 years on median.
- 7 of the 96 ancestors have a recall of any class.
- Of its descendants, K131343 (Spinal USA, 2013) has gone furthest, with 31 descendants of its own.
- 9 other devices also cite its predicate K071438.
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 ReForm Pedicle Screw 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 (150 words)
The ReForm Pedicle Screw 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 (pseudarthrosis).
The ReForm Pedicle Screw 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/K121172 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121172: Reform Pedicle Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121172
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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