510(k) · Cleared
ClearedBar Pedicle Screw Spinal Fixation System, Model 2020
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Applied Spine Technologies, Inc. · MNH Orthosis, Spondylolisthesis Spinal Fixation
Cleared on Jul 26, 2006 as substantially equivalent to K031511 (Centerpulse Spine-Tech, Inc., 2004) and 2 other predicates after a 91-day review. Its family tree reaches back 5 generations to 1990. 131 later devices descend from it.
- Decided
- Jul 26, 2006
- Review
- 91 days
- Class
- Class II
- Product code
- MNH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K901587 (1990). 35 ancestors in all. 131 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK901587 TSRH Sacral L-ConnectorDanek Medical, Inc. · 1990
- 4 generations backK950099 Synergy (TM) TI Posterior Spinal SystemBuckman Co., Inc. · 1997
- 3 generations backK973836 Synergy 6.35MM SS Rod with Screws for Anterior Use, Part of the…Cross Medical Products, Inc. · 1998
- 2 generations backK980484 Aesculap Spine System EvolutionAesculap, Inc. · 1998
- 1 generation backK990118 Isobar Spinal SystemScien'Tx USA, Inc. · 1999
- This deviceK061162 Bar Pedicle Screw Spinal Fixation System, Model 2020Applied Spine Technologies, Inc. · 2006
- Descendant · cites it directly · 130 of its ownK092624 Firebird Spinal Fixation SystemBlackstone Medical, Inc. · 2009 · Recalled
- Descendant · 2 generations on · 117 of its ownK100044 Firebird Spinal Fixation System, Firebird Side-Loading BodyBlackstone · 2010
- Descendant · 2 generations on · 116 of its ownK122901 Firebird Spinal Fixation System, Phoenix Mis Spinal Fixation SystemOrthofix · 2012
- Descendant · 2 generations on · 88 of its ownK093926 Firebird Spinal Fixation SystemBlackstone Medical, Inc. · 2010
- Descendant · 3 generations on · 81 of its ownK130932 Firebird Spinal Fixation SystemOrthofix, Inc. · 2013 · Recalled
Showing 5 of 131 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 131 · See all- K092624Firebird Spinal Fixation SystemBlackstone Medical, Inc. · 2009 · cites it directly130descendants
- K100044Firebird Spinal Fixation System, Firebird Side-Loading BodyBlackstone · 2010 · 2 generations on117descendants
- K122901Firebird Spinal Fixation System, Phoenix Mis Spinal Fixation SystemOrthofix · 2012 · 2 generations on116descendants
- K093926Firebird Spinal Fixation SystemBlackstone Medical, Inc. · 2010 · 2 generations on88descendants
- K130932Firebird Spinal Fixation SystemOrthofix, Inc. · 2013 · 3 generations on81descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K901587 | TSRH Sacral L-Connector | Danek Medical, Inc. | 1990 | — |
| −4 | K950099 | Synergy (TM) TI Posterior Spinal System | Buckman Co., Inc. | 1997 | — |
| −3 | K973836 | Synergy 6.35MM SS Rod with Screws for Anterior Use, Part of the Cross… | Cross Medical Products, Inc. | 1998 | — |
| −2 | K980484 | Aesculap Spine System Evolution | Aesculap, Inc. | 1998 | — |
| −1 | K990118 | Isobar Spinal System | Scien'Tx USA, Inc. | 1999 | — |
| 0 (this device) | K061162 | Bar Pedicle Screw Spinal Fixation System, Model 2020 | Applied Spine Technologies, Inc. | 2006 | — |
| +1 | K092624 | Firebird Spinal Fixation System | Blackstone Medical, Inc. | 2009 | 1 |
| +2 | K100044 | Firebird Spinal Fixation System, Firebird Side-Loading Body | Blackstone | 2010 | — |
| +2 | K122901 | Firebird Spinal Fixation System, Phoenix Mis Spinal Fixation System | Orthofix | 2012 | — |
| +2 | K093926 | Firebird Spinal Fixation System | Blackstone Medical, Inc. | 2010 | — |
| +3 | K130932 | Firebird Spinal Fixation System | Orthofix, Inc. | 2013 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1992 | 5 | 0 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 3 | 0 |
| 1996 | 4 | 0 |
| 1997 | 2 | 0 |
| 1998 | 3 | 0 |
| 1999 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 4 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 4 | 0 |
| 2014 | 2 | 0 |
| 2015 | 4 | 0 |
| 2016 | 6 | 0 |
| 2017 | 11 | 0 |
| 2018 | 7 | 0 |
| 2019 | 9 | 0 |
| 2020 | 8 | 0 |
| 2021 | 9 | 0 |
| 2022 | 13 | 0 |
| 2023 | 15 | 0 |
| 2024 | 11 | 0 |
| 2025 | 14 | 0 |
| 2026 | 13 | 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? (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 |
|---|---|---|---|
| * | K031511 | Dynesys Spinal SystemSummary page 1…lassification Name: Class IIper 21 CFR Section 888.3070 Product Code: MNI/MNH Equivalent Devices: Dynesys® Dynamic Stabilization System (K031511) Manufactured and distributed by: Zimmer, Inc.… | 2004 |
| * | K990118 | Isobar Spinal SystemSummary page 1…nd distributed by: Zimmer, Inc. ISOBAR TTL Semi-Rigid Pedicle Screw Fusion System (K990118) SCIENT'X USA CD Horizon® Spinal System (K043488)… | 1999 |
| * | K043488 | Modification to CD Horizon Spinal SystemSummary page 1…igid Pedicle Screw Fusion System (K990118) SCIENT'X USA CD Horizon® Spinal System (K043488) Medtronic Sofamor Danek Device Description: The BAR Pedicle Screw Fixation System consists of pedic… | 2005 |
What descends from it? (131)
See all 1311 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K092624 | Firebird Spinal Fixation System | 2009 | 130 |
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 16 years and passes through 6 companies; a new generation was cleared every 1.1 years on median.
- 2 of the 35 ancestors have a recall of any class.
- Of its descendants, K092624 (Blackstone Medical, Inc., 2009) has gone furthest, with 130 descendants of its own.
- 7 other devices also cite its predicate K031511.
How does its category compare?
All MNH devicesMNH Orthosis, Spondylolisthesis Spinal Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 BAR Pedicle Screw Spinal Fixation System is intended for posterior non cervical pedicle screw fixation in the lumbo-sacral spine 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 lumbar or sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture…
Read the full statement (130 words)
The BAR Pedicle Screw Spinal Fixation System is intended for posterior non cervical pedicle screw fixation in the lumbo-sacral spine 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 lumbar or sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis).
In addition the BAR Pedicle Screw Spinal Fixation System, used as a pedicle screw fixation system is intended for:
a. Patients receiving only autogenous bone graft.
b. Patients having the device fixed or attached to the lumbar and sacral spine and having severe spondylolisthesis grade 3 or 4 at the fifth lumbar-first sacral (L5-Sl) vertebral joint.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061162 · printed Nov 6, 2026
Cite this page
510(k) Report. “K061162: Bar Pedicle Screw Spinal Fixation System, Model 2020.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061162
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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