510(k) · Cleared
Recalled · Class II · 2015Spinefrontier 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 Feb 15, 2013 as substantially equivalent to K092420 (Spinefrontier, Inc., 2009) and 4 other predicates after a 129-day review. Its family tree reaches back 8 generations to 1995. 3 later devices descend from it. It has been recalled 6 times.
- Decided
- Feb 15, 2013
- Review
- 129 days
- Class
- Class II
- Product code
- MNH
- Recalls
- 6
- Predicates
- 5
Its longest line of descent runs back 8 generations to K951116 (1995). 55 ancestors in all, the oldest K901587 (1990). 3 later devices descend from it, 3 citing it directly.
- Root · 8 generations backK951116 Acromed Pedicle ScrewAcromed Corp. · 1995
- 7 generations backK963639 Acromed Pedicle ScrewAcromed Corp. · 1996
- 6 generations backK982511 Depuy Motech Moss Miami Spinal SystemsDepuy, Inc. · 1998
- 5 generations backK030383 Modification to Moss Miami Spinal System Polyaxial ScrewsDepuyacromed · 2003
- 4 generations backK070245 Capsure Pedicle Screw SystemSpine Wave, Inc. · 2007
- 3 generations backK081228 Capsure PS (R) Spine SystemSpine Wave, Inc. · 2008
- 2 generations backK083353 Capsure (R) PS SystemSpine Wave, Inc. · 2008
- 1 generation backK100605 Mis SystemSpine Wave, Inc. · 2010
- This deviceK123164 Spinefrontier Pedfuse Pedicle Screw SystemSpinefrontier, Inc. · 2013
- Descendant · cites it directly · 1 of its ownK133153 Spinefrontier Pedfuse Pedicle Screw SystemSpinefrontier, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK191655 MEGAFIX® Pedicle Screw Spinal SystemSeohancare Co., Ltd. · 2020
- Descendant · cites it directly · 0 of its ownK143377 PedFuse Pedicle Screw SystemSpinefrontier, Inc. · 2015
Most influential descendants
Showing 3 of 3 · See all- K133153Spinefrontier Pedfuse Pedicle Screw SystemSpinefrontier, Inc. · 2014 · cites it directly1descendant
- K191655MEGAFIX® Pedicle Screw Spinal SystemSeohancare Co., Ltd. · 2020 · cites it directly0descendants
- 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 |
|---|---|---|---|---|---|
| −8 | K951116 | Acromed Pedicle Screw | Acromed Corp. | 1995 | — |
| −7 | K963639 | Acromed Pedicle Screw | Acromed Corp. | 1996 | — |
| −6 | K982511 | Depuy Motech Moss Miami Spinal Systems | Depuy, Inc. | 1998 | — |
| −5 | K030383 | Modification to Moss Miami Spinal System Polyaxial Screws | Depuyacromed | 2003 | — |
| −4 | K070245 | Capsure Pedicle Screw System | Spine Wave, Inc. | 2007 | — |
| −3 | K081228 | Capsure PS (R) Spine System | Spine Wave, Inc. | 2008 | — |
| −2 | K083353 | Capsure (R) PS System | Spine Wave, Inc. | 2008 | — |
| −1 | K100605 | Mis System | Spine Wave, Inc. | 2010 | — |
| 0 (this device) | K123164 | Spinefrontier Pedfuse Pedicle Screw System | Spinefrontier, Inc. | 2013 | — |
| +1 | K133153 | Spinefrontier Pedfuse Pedicle Screw System | Spinefrontier, Inc. | 2014 | — |
| +1 | K191655 | MEGAFIX® Pedicle Screw Spinal System | Seohancare Co., Ltd. | 2020 | — |
| +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 | 2 | 0 |
| 1998 | 4 | 0 |
| 1999 | 4 | 0 |
| 2000 | 3 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 3 | 0 |
| 2004 | 7 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2020 | 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 |
|---|---|---|---|
| * | K092420 | KRD1 Pedicle Screw SystemSummary page 1…inal Pedicle Fixation (21 CFR 888.3070(b)(1)), Class 11 Product Code: MNH, MNI 3. Predicate Devices K092420 - SpineFrontier® KRD 1 TM Pedicle Screw System K950099 - Synergy Posterior Spinal System K992739 - Synthes USS… | 2009 |
| * | K950099 | Synergy (TM) TI Posterior Spinal SystemSummary page 1…88.3070(b)(1)), Class 11 Product Code: MNH, MNI 3. Predicate Devices K092420 - SpineFrontier® KRD 1 TM Pedicle Screw System K950099 - Synergy Posterior Spinal System K992739 - Synthes USS Click-X Variable Axis System K1 00605 - Spine Wave MIS… | 1997 |
| * | K992739 | Click'xSummary page 1…MNH, MNI 3. Predicate Devices K092420 - SpineFrontier® KRD 1 TM Pedicle Screw System K950099 - Synergy Posterior Spinal System K992739 - Synthes USS Click-X Variable Axis System K1 00605 - Spine Wave MIS Pedicle Screw System K061591 - Medtronic C… | 2000 |
| * | K100605 | Mis SystemSummary page 1…20 - SpineFrontier® KRD 1 TM Pedicle Screw System K950099 - Synergy Posterior Spinal System K992739 - Synthes USS Click-X Variable Axis System K1 00605 - Spine Wave MIS Pedicle Screw System K061591 - Medtronic CID Horizon Spinal System 4. Device Description… | 2010 |
| * | K061591 | Modification to CD Horizon Spinal SystemSummary page 1…K950099 - Synergy Posterior Spinal System K992739 - Synthes USS Click-X Variable Axis System K1 00605 - Spine Wave MIS Pedicle Screw System K061591 - Medtronic CID Horizon Spinal System 4. Device Description The SpineFrontier® PedFuse® Pedicle Screw System cons… | 2006 |
What descends from it? (3)
3 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 5, 2015 | Class II | Z-1479-2015 | Labeling design | The PedFuse Pedicle Screw Rod Caliper included with the MISquito Pedicle Screw System may be used incorrectly as the Surgical Technique does not adequately convey the intended use of the design. |
| Nov 20, 2013 | Class II | Z-0554-2014 | Device Design | Screw inserters may not mate properly with hex interface of the screws. |
| Nov 20, 2013 | Class II | Z-0555-2014 | Device Design | Screw inserters may not mate properly with hex interface of the screws. |
| Nov 20, 2013 | Class II | Z-0553-2014 | Device Design | Screw inserters may not mate properly with hex interface of the screws. |
| Oct 18, 2013 | Class II | Z-0544-2014 | Software design (manufacturing process) | During routine servicing, it was discovered that one 8mmx55mm Reset screw was assembled with an 8mm tulip head and a 9mm screw. The implant should have consisted of an 8mm tulip head and an 8mm screw. A recall was initiated to remove all… |
| Sep 11, 2013 | Class II | Z-0624-2014 | Process change control | Bone Probes used to create a pathway in pedicle bone were manufactured and marked to incorrect specifications. |
The 5 latest of 6 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 18 years and passes through 5 companies; a new generation was cleared every 1.8 years on median.
- 6 of the 55 ancestors have a recall of any class.
- Of its descendants, K133153 (Spinefrontier, Inc., 2014) has gone furthest, with 1 descendant of its own.
- 4 other devices also cite its predicate K092420.
How does its category compare?
All MNH devicesMNH Orthosis, Spondylolisthesis Spinal Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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® PedFuse® 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 (209 words)
The SpineFrontier® PedFuse® 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 spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, with the device fixed or attached to the lumbar and sacral spine.
When used in a percutaneous approach with MIS instrumentation, the SpineFrontier® PedFuse® 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 (Pseudarthrosis) and severe spondylolisthesis (Grade 3 and 4) of the L5-SI 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/K123164 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123164: 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/K123164
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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