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 Jun 20, 2013 as substantially equivalent to K121172 (Spinal USA, 2012) and 5 other predicates after a 135-day review. Its family tree reaches back 14 generations to 1985. 31 later devices descend from it.
- Decided
- Jun 20, 2013
- Review
- 135 days
- Class
- Class II
- Product code
- MNI
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 14 generations to K853033 (1985). 130 ancestors in all, the oldest K841189 (1984). 31 later devices descend from it, 3 citing it directly.
- Root · 14 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 10 generations between
- 3 generations backK080313 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2008
- 2 generations backK111571 Viper SystemsJohnson & Johnson · 2011
- 1 generation backK121172 Reform Pedicle Screw SystemSpinal USA · 2012
- This deviceK130279 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
- Descendant · cites it directly · 19 of its ownK151422 Reform Pedicle Screw SystemPrecision Spine, Inc. · 2015
- Descendant · 2 generations on · 10 of its ownK200303 Reform Pedicle Screw SystemPrecision Spine · 2020
Show all 14 generations
- Root · 14 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 13 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
- 12 generations backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
- 11 generations backK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
- 10 generations backK013222 Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed · 2001
- 9 generations backK022190 Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2002
- 8 generations backK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
- 7 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
- 6 generations backK062174 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- 5 generations backK063156 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- 4 generations backK063741 Expedium Spine SystemDepuy Spine, Inc. · 2007
- 3 generations backK080313 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2008
- 2 generations backK111571 Viper SystemsJohnson & Johnson · 2011
- 1 generation backK121172 Reform Pedicle Screw SystemSpinal USA · 2012
- This deviceK130279 Reform Pedicle Screw SystemSpinal USA · 2013
Showing 5 of 31 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 31 · See all- 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
- K151422Reform Pedicle Screw SystemPrecision Spine, Inc. · 2015 · cites it directly19descendants
- K200303Reform Pedicle Screw SystemPrecision Spine · 2020 · 2 generations on10descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K853033 | Hartshill Rect & Wires, Spinal Fixation System | A.W. Showell (Surgicraft), Ltd. | 1985 | — |
| −13 | K965221 | Ransford Cervical Fixation System | Surgicraft, Ltd. | 1997 | — |
| −12 | K982322 | Synthes Spine Occipital-Cervical Plate/Rod and Hook System | Synthes (Usa) | 1998 | — |
| −11 | K002733 | Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2000 | — |
| −10 | K013222 | Summit Occipito-Cervico- Thoracic (Oct) Spinal System | Depuyacromed | 2001 | — |
| −9 | K022190 | Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2002 | — |
| −8 | K030103 | Summit Oct Spinal System Minipolyaxial Screws | Depuyacromed | 2003 | — |
| −7 | K041203 | Summit Oct Spinal System | Depuy Spine, Inc. | 2004 | — |
| −6 | K062174 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2006 | — |
| −5 | K063156 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2006 | — |
| −4 | K063741 | Expedium Spine System | Depuy Spine, Inc. | 2007 | — |
| −3 | K080313 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2008 | — |
| −2 | K111571 | Viper Systems | Johnson & Johnson | 2011 | — |
| −1 | K121172 | Reform Pedicle Screw System | Spinal USA | 2012 | — |
| 0 (this device) | 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 | — |
| +1 | K151422 | Reform Pedicle Screw System | Precision Spine, Inc. | 2015 | — |
| +2 | K200303 | Reform Pedicle Screw System | Precision Spine | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 4 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 8 | 0 |
| 1999 | 9 | 0 |
| 2000 | 11 | 0 |
| 2001 | 14 | 0 |
| 2002 | 6 | 0 |
| 2003 | 8 | 0 |
| 2004 | 13 | 0 |
| 2005 | 12 | 0 |
| 2006 | 7 | 0 |
| 2007 | 7 | 0 |
| 2008 | 6 | 0 |
| 2009 | 4 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (6)
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 |
|---|---|---|---|
| * | K121172 | Reform Pedicle Screw SystemSummary page 1…d §888.3050 J Product Codes: MNI MNH KWP rClassificalion Panel: H Orthopedic and Rehabilitation Devices Panel Predicate Devices: PSS System (ReForm Pedicle Screw System), K121172, K092128, K090033, K073240, KO71438 Biomet 5.5 Polaris Spinal System K091067 DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTI… | 2012 |
| * | K092128 | Modification to: PSS SystemSummary page 1…50 J Product Codes: MNI MNH KWP rClassificalion Panel: H Orthopedic and Rehabilitation Devices Panel Predicate Devices: PSS System (ReForm Pedicle Screw System), K121172, K092128, K090033, K073240, KO71438 Biomet 5.5 Polaris Spinal System K091067 DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:… | 2009 |
| * | K090033 | Modification to: PSS SystemSummary page 1…uct Codes: MNI MNH KWP rClassificalion Panel: H Orthopedic and Rehabilitation Devices Panel Predicate Devices: PSS System (ReForm Pedicle Screw System), K121172, K092128, K090033, K073240, KO71438 Biomet 5.5 Polaris Spinal System K091067 DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION: The Ref… | 2009 |
| * | K073240 | PSS SystemSummary page 1…: MNI MNH KWP rClassificalion Panel: H Orthopedic and Rehabilitation Devices Panel Predicate Devices: PSS System (ReForm Pedicle Screw System), K121172, K092128, K090033, K073240, KO71438 Biomet 5.5 Polaris Spinal System K091067 DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION: The Reform Syste… | 2008 |
| * | K071438 | PSS SystemSummary page 1…this submission is to make modifications/additions to the components of the PSS System (ReForm Pedicle Screw System) cleared in K121172, K092128, K090033, K073240, ' and K071438. The standard construct is modified by the addition of hooks and rod to rod connectors. ' ReForm Pedicle Screw System IHooks and… | 2007 |
| * | K091067 | 5.5 Polaris Spinal SystemSummary page 1…nd Rehabilitation Devices Panel Predicate Devices: PSS System (ReForm Pedicle Screw System), K121172, K092128, K090033, K073240, KO71438 Biomet 5.5 Polaris Spinal System K091067 DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION: The Reform System is a top-loading, multiple component, posterior… | 2009 |
What descends from it? (31)
See all 313 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 28 years and passes through 7 companies; a new generation was cleared every 1.3 years on median.
- 10 of the 130 ancestors have a recall of any class.
- Of its descendants, K143248 (Precision Spine, Inc., 2014) has gone furthest, with 30 descendants of its own.
- 4 other devices also cite its predicate K121172.
How does its category compare?
All MNI devicesMNI Orthosis, Spinal Pedicle Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 scgments in skeletally maturc patients as an adjunct to fusion in the trecatment of the following acute and chronic instabilities or deformitics of thoracic, Jumbar, 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 (148 words)
The ReForm Pedicle Screw System is intended to provide immobilization and stabilization of spinal scgments in skeletally maturc patients as an adjunct to fusion in the trecatment of the following acute and chronic instabilities or deformitics of thoracic, Jumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment. fracture. dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pscudarthrosis).
The ReForm Pedicle Screw Svstem is also intended for non-cervical pedicle screw fixation for the lollowing indications: severe spondylolisthesis (grades 3und 4of the 1.5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (1.3 to sacrum) with removal of the implants afier the attainment of a solid [usion. It is also intended {or the following indications: trauma (i.c. fracture or dislocation); spinal stenosis; curvatures (i.c. scoliosis. kKyphosis; and/or lordosis) spinal tumor; pseudloarthrosis; and failed previous fusion.
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/K130279 · printed Nov 4, 2026
Cite this page
510(k) Report. “K130279: Reform Pedicle Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K130279
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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