510(k) · Cleared
ClearedJ.B.S. Spine System with Pedicle Screws - Additional Components - Screws, Linking Plates, Hooks and Rod Clamp
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
J.B.S., S.A. · MNH Orthosis, Spondylolisthesis Spinal Fixation
Cleared on Sep 25, 1996 after a 71-day review. The FDA summary names its predicate without a number. 257 later devices descend from it.
- Decided
- Sep 25, 1996
- Review
- 71 days
- Class
- Class II
- Product code
- MNH
- Recalls
- None
- Predicates
- 0
257 later devices descend from it, 3 citing it directly.
- This deviceK962757 J.B.S. Spine System with Pedicle Screws - Additional Components -…J.B.S., S.A. · 1996
- Descendant · cites it directly · 251 of its ownK982914 Aesculap Spine System Evolution: Additional ComponentsAesculap, Inc. · 1998
- Descendant · cites it directly · 251 of its ownK980484 Aesculap Spine System EvolutionAesculap, Inc. · 1998
- Descendant · 2 generations on · 250 of its ownK990118 Isobar Spinal SystemScien'Tx USA, Inc. · 1999
- Descendant · 3 generations on · 131 of its ownK061162 Bar Pedicle Screw Spinal Fixation System, Model 2020Applied Spine Technologies, Inc. · 2006
- Descendant · 4 generations on · 130 of its ownK092624 Firebird Spinal Fixation SystemBlackstone Medical, Inc. · 2009 · Recalled
Showing 5 of 257 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 257 · See all- K982914Aesculap Spine System Evolution: Additional ComponentsAesculap, Inc. · 1998 · cites it directly251descendants
- K980484Aesculap Spine System EvolutionAesculap, Inc. · 1998 · cites it directly251descendants
- K990118Isobar Spinal SystemScien'Tx USA, Inc. · 1999 · 2 generations on250descendants
- K061162Bar Pedicle Screw Spinal Fixation System, Model 2020Applied Spine Technologies, Inc. · 2006 · 3 generations on131descendants
- K092624Firebird Spinal Fixation SystemBlackstone Medical, Inc. · 2009 · 4 generations on130descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K962757 | J.B.S. Spine System with Pedicle Screws - Additional Components - Screws… | J.B.S., S.A. | 1996 | — |
| +1 | K982914 | Aesculap Spine System Evolution: Additional Components | Aesculap, Inc. | 1998 | — |
| +1 | K980484 | Aesculap Spine System Evolution | Aesculap, Inc. | 1998 | — |
| +2 | K990118 | Isobar Spinal System | Scien'Tx USA, Inc. | 1999 | — |
| +3 | K061162 | Bar Pedicle Screw Spinal Fixation System, Model 2020 | Applied Spine Technologies, Inc. | 2006 | — |
| +4 | K092624 | Firebird Spinal Fixation System | Blackstone Medical, Inc. | 2009 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 5 | 0 |
| 2005 | 1 | 0 |
| 2006 | 3 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 4 | 0 |
| 2012 | 7 | 0 |
| 2013 | 7 | 0 |
| 2014 | 6 | 0 |
| 2015 | 9 | 0 |
| 2016 | 14 | 0 |
| 2017 | 17 | 0 |
| 2018 | 13 | 0 |
| 2019 | 14 | 0 |
| 2020 | 18 | 0 |
| 2021 | 13 | 0 |
| 2022 | 17 | 0 |
| 2023 | 23 | 0 |
| 2024 | 28 | 0 |
| 2025 | 26 | 0 |
| 2026 | 18 | 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 |
|---|---|---|---|
| * | — | TSRH System by Sofamor Danek Named without a submission number | |
| * | — | PLSA System by Advanced Spine Fixation Systems Named without a submission number | |
| * | — | Rogozinsky System by Richards Named without a submission number | |
| * | — | Harrington System by Zimmer Named without a submission number | |
| * | — | C-D System by Stuart (Danek) Named without a submission number |
What descends from it? (257)
See all 2573 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?
- Of its descendants, K982914 (Aesculap, Inc., 1998) has gone furthest, with 251 descendants of its own.
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?
When usad asanon cervical hook and sacral screw system, the JB.S. Spine System is indicated for use in patients with degenerative disc disease wiously fafled back surgeries, and fractures. When used as a pedicle screw system, it is intended for patiens (a) having severe spondylolisthesis (grades 3 and 4) at the 1L5-S1 joint, who are receiving fusion using auogenous bone graft anly, (c) who are having the device fixed or attached to the lumber and sacral…
Read the full statement (135 words)
When usad asanon cervical hook and sacral screw system, the JB.S. Spine System is indicated for use in patients with degenerative disc disease wiously fafled back surgeries, and fractures. When used as a pedicle screw system, it is intended for patiens (a) having severe spondylolisthesis (grades 3 and 4) at the 1L5-S1 joint, who are receiving fusion using auogenous bone graft anly, (c) who are having the device fixed or attached to the lumber and sacral spine; and (d) who are having the device temoved after development of a solid fission mass. The JB.S. Spine System, as a whole, is infended for posterior fixation from levels T1 through S1. The Sacral Plates are intended for posterior sacral fixation atS1and S2. Levels of pedicle screw fixation are posterior fixation from levels L3 to through S1 only.
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/K962757 · printed Nov 5, 2026
Cite this page
510(k) Report. “K962757: J.B.S. Spine System with Pedicle Screws - Additional Components - Screws, Linking Plates, Hooks and Rod Clamp.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K962757
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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