510(k) · Cleared
ClearedSpinefrontier Pedfuse Pedicle Screw System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spinefrontier, Inc. · MNH Orthosis, Spondylolisthesis Spinal Fixation
Cleared on May 14, 2014 as substantially equivalent to K123164 (Spinefrontier, Inc., 2013) and 4 other predicates after a 209-day review. Its family tree reaches back 9 generations to 1995. 1 later device descends from it.
- Decided
- May 14, 2014
- Review
- 209 days
- Class
- Class II
- Product code
- MNH
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 9 generations to K951116 (1995). 102 ancestors in all, the oldest K901587 (1990). 1 later device descends from it, 1 citing it directly.
- Root · 9 generations backK951116 Acromed Pedicle ScrewAcromed Corp. · 1995
- 5 generations between
- 3 generations backK083353 Capsure (R) PS SystemSpine Wave, Inc. · 2008
- 2 generations backK100605 Mis SystemSpine Wave, Inc. · 2010
- 1 generation backK123164 Spinefrontier Pedfuse Pedicle Screw SystemSpinefrontier, Inc. · 2013 · Recalled
- This deviceK133153 Spinefrontier Pedfuse Pedicle Screw SystemSpinefrontier, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK143377 PedFuse Pedicle Screw SystemSpinefrontier, Inc. · 2015
Show all 9 generations
- Root · 9 generations backK951116 Acromed Pedicle ScrewAcromed Corp. · 1995
- 8 generations backK963639 Acromed Pedicle ScrewAcromed Corp. · 1996
- 7 generations backK982511 Depuy Motech Moss Miami Spinal SystemsDepuy, Inc. · 1998
- 6 generations backK030383 Modification to Moss Miami Spinal System Polyaxial ScrewsDepuyacromed · 2003
- 5 generations backK070245 Capsure Pedicle Screw SystemSpine Wave, Inc. · 2007
- 4 generations backK081228 Capsure PS (R) Spine SystemSpine Wave, Inc. · 2008
- 3 generations backK083353 Capsure (R) PS SystemSpine Wave, Inc. · 2008
- 2 generations backK100605 Mis SystemSpine Wave, Inc. · 2010
- 1 generation backK123164 Spinefrontier Pedfuse Pedicle Screw SystemSpinefrontier, Inc. · 2013 · Recalled
- This deviceK133153 Spinefrontier Pedfuse Pedicle Screw SystemSpinefrontier, Inc. · 2014
Most influential descendants
Showing 1 of 1 · See all- K143377PedFuse Pedicle Screw SystemSpinefrontier, Inc. · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K951116 | Acromed Pedicle Screw | Acromed Corp. | 1995 | — |
| −8 | K963639 | Acromed Pedicle Screw | Acromed Corp. | 1996 | — |
| −7 | K982511 | Depuy Motech Moss Miami Spinal Systems | Depuy, Inc. | 1998 | — |
| −6 | K030383 | Modification to Moss Miami Spinal System Polyaxial Screws | Depuyacromed | 2003 | — |
| −5 | K070245 | Capsure Pedicle Screw System | Spine Wave, Inc. | 2007 | — |
| −4 | K081228 | Capsure PS (R) Spine System | Spine Wave, Inc. | 2008 | — |
| −3 | K083353 | Capsure (R) PS System | Spine Wave, Inc. | 2008 | — |
| −2 | K100605 | Mis System | Spine Wave, Inc. | 2010 | — |
| −1 | K123164 | Spinefrontier Pedfuse Pedicle Screw System | Spinefrontier, Inc. | 2013 | 6 |
| 0 (this device) | K133153 | Spinefrontier Pedfuse Pedicle Screw System | Spinefrontier, Inc. | 2014 | — |
| +1 | K143377 | PedFuse Pedicle Screw System | Spinefrontier, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 2 | 0 |
| 1992 | 5 | 0 |
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 3 | 0 |
| 1997 | 3 | 0 |
| 1998 | 5 | 0 |
| 1999 | 4 | 0 |
| 2000 | 8 | 0 |
| 2001 | 4 | 0 |
| 2002 | 6 | 0 |
| 2003 | 8 | 0 |
| 2004 | 12 | 0 |
| 2005 | 9 | 0 |
| 2006 | 6 | 0 |
| 2007 | 6 | 0 |
| 2008 | 3 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 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 MNH? 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 |
|---|---|---|---|
| * | K123164 | Spinefrontier Pedfuse Pedicle Screw SystemSummary page 1…ANGE FROM PREVIOUSLY CLEARED SYSTEM The purpose of this submission is to make additions to the components of the SpineFrontier®) Ped~use@ Pedicle Screw System cleared in K 123 164 and K092420. Hydroxyapatite (HA)- SpineFrontier® PedFuse® Pedicle Screw System === Page 2… | 2013 |
| * | K092420 | KRD1 Pedicle Screw SystemSummary page 1…abilitation Devices Panel Predicate Devices: SpineFrontier®)PedFuse®)Pedicle Screw System (KI 23164, K092420) Medtronic TSRH®0 Spinal System (K091797)… | 2009 |
| * | K091797 | TSRH Spinal SystemSummary page 1…PedFuse®)Pedicle Screw System (KI 23164, K092420) Medtronic TSRH®0 Spinal System (K091797) Pioneer Quantum Spinal System (K 10 1790)… | 2010 |
| * | K101790 | Quantum Spinal System, Quantum MisSummary page 1…K092420) Medtronic TSRH®0 Spinal System (K091797) Pioneer Quantum Spinal System (K 10 1790) Globus Transition' Stabilization System (K073439) DESCRIPTION OF THE DEVICE The S… | 2011 |
| * | K073439 | Transition Stabilization SystemSummary page 1…Pioneer Quantum Spinal System (K 10 1790) Globus Transition' Stabilization System (K073439) DESCRIPTION OF THE DEVICE The SpineFrontier®)PedFuse®& Pedicle Screw System is intended to help provide immobilization and… | 2009 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K143377 | PedFuse Pedicle Screw System | 2015 | 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 19 years and passes through 5 companies; a new generation was cleared every 1.5 years on median.
- 14 of the 102 ancestors have a recall of any class.
- Of its descendants, K143377 (Spinefrontier, Inc., 2015) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K123164.
How does its category compare?
All MNH devicesMNH Orthosis, Spondylolisthesis Spinal Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · MNH
8in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · MNH
93in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MNH
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MNH
89in 2025
MAUDE reports naming product code MNH, 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 | 5 | 123 | 0 | 18 |
| 2008 | 13 | 65 | 0 | 30 |
| 2009 | 13 | 151 | 7 | 45 |
| 2010 | 10 | 106 | 0 | 59 |
| 2011 | 17 | 171 | 0 | 107 |
| 2012 | 7 | 93 | 1 | 433 |
| 2013 | 10 | 124 | 1 | 464 |
| 2014 | 12 | 140 | 0 | 286 |
| 2015 | 10 | 99 | 0 | 152 |
| 2016 | 8 | 93 | 1 | 216 |
| 2017 | 0 | — | 0 | 174 |
| 2018 | 0 | — | 0 | 129 |
| 2019 | 0 | — | 0 | 403 |
| 2020 | 0 | — | 0 | 432 |
| 2021 | 0 | — | 0 | 531 |
| 2022 | 0 | — | 0 | 265 |
| 2023 | 0 | — | 0 | 121 |
| 2024 | 0 | — | 0 | 302 |
| 2025 | 0 | — | 0 | 89 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The SpineFrontier®V Ped~uset 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 instabilities or deformities of the 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 (207 words)
The SpineFrontier®V Ped~uset 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 instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis. kyphosis, spinal tumor, and failed previous fusion (Pseudarthrosis).
In addition, the SpineFrontier® PedFuse®&Pedicle Screw System is indicated for the treatment of severe spandylolisthesis (Grade 3 and 4) of the L5-SI vertebra in skeletally mature patients receiving fusion by autogenous bane graft, with the device fixed or attached to the lumbar and sacral spine.
When used in a percutaneous approach with MIS instrumentation, the SpineFrontier®&Ped~use®9 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 instabilities or deformities of the thoracic. lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, failed previous fusion (Pseitidarthrosis) and severe spondylolisthesis (Grade 3 and 4) of the L5-SlI vertebra in skeletally mature patients receiving fusion by autogenous bone graft, with the device fixed or attached to the lumbar and sacral spine.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133153 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133153: Spinefrontier Pedfuse 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/K133153
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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