510(k) · Cleared
ClearedS 100 Pedicle Screw System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Renovis Surgical Technologies, LLC · MNH Orthosis, Spondylolisthesis Spinal Fixation
Cleared on May 15, 2012 as substantially equivalent to K042673 (Alphatec/Nexmed, 2004) and 2 other predicates after a 312-day review. Its family tree reaches back 7 generations to 1995. 19 later devices descend from it.
- Decided
- May 15, 2012
- Review
- 312 days
- Class
- Class II
- Product code
- MNH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K950697 (1995). 25 ancestors in all. 19 later devices descend from it, 7 citing it directly.
- Root · 7 generations backK950697 Depuy Motech Moss Miami Spinal System - Pedicle FixationDepuy Motech · 1995
- 6 generations backK050461 Xia 4.5 Spinal SystemStryker Spine · 2005
- 5 generations backK052761 Modification to: Xia 4.5 Spinal SystemStryker Spine · 2005
- 4 generations backK060361 Xia Spinal System, Xia 4.5 Spinal SystemStryker Spine · 2006 · Recalled
- 3 generations backK060979 Xia Titanium and 4.5 Spinal SystemsStryker Spine · 2006
- 2 generations backK071373 Stryker Spine Xia Iii Spinal SystemStryker Spine · 2007 · Recalled
- 1 generation backK083393 Xia 3 Spinal SystemStryker Spine · 2009 · Recalled
- This deviceK111940 S 100 Pedicle Screw SystemRenovis Surgical Technologies, LLC · 2012
- Descendant · cites it directly · 6 of its ownK162764 Jazz Frame SystemImplanet, S.A. · 2017
- Descendant · 2 generations on · 5 of its ownK170730 JAZZ System, including JAZZ BandImplanet, S.A. · 2017
- Descendant · 3 generations on · 3 of its ownK222097 OLYMPIC Deformity Band SystemAstura Medical · 2023
- Descendant · cites it directly · 3 of its ownK173180 Mega Plus Spine SystemBk Meditech, Co., Ltd. · 2018
- Descendant · 4 generations on · 2 of its ownK231694 MASADA Modular Spinal Fixation SystemAstura Medical · 2023
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 19 · See all- K162764Jazz Frame SystemImplanet, S.A. · 2017 · cites it directly6descendants
- K170730JAZZ System, including JAZZ BandImplanet, S.A. · 2017 · 2 generations on5descendants
- K222097OLYMPIC Deformity Band SystemAstura Medical · 2023 · 3 generations on3descendants
- K173180Mega Plus Spine SystemBk Meditech, Co., Ltd. · 2018 · cites it directly3descendants
- K231694MASADA Modular Spinal Fixation SystemAstura Medical · 2023 · 4 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K950697 | Depuy Motech Moss Miami Spinal System - Pedicle Fixation | Depuy Motech | 1995 | — |
| −6 | K050461 | Xia 4.5 Spinal System | Stryker Spine | 2005 | — |
| −5 | K052761 | Modification to: Xia 4.5 Spinal System | Stryker Spine | 2005 | — |
| −4 | K060361 | Xia Spinal System, Xia 4.5 Spinal System | Stryker Spine | 2006 | 1 |
| −3 | K060979 | Xia Titanium and 4.5 Spinal Systems | Stryker Spine | 2006 | — |
| −2 | K071373 | Stryker Spine Xia Iii Spinal System | Stryker Spine | 2007 | 1 |
| −1 | K083393 | Xia 3 Spinal System | Stryker Spine | 2009 | 1 |
| 0 (this device) | K111940 | S 100 Pedicle Screw System | Renovis Surgical Technologies, LLC | 2012 | — |
| +1 | K162764 | Jazz Frame System | Implanet, S.A. | 2017 | — |
| +2 | K170730 | JAZZ System, including JAZZ Band | Implanet, S.A. | 2017 | — |
| +3 | K222097 | OLYMPIC Deformity Band System | Astura Medical | 2023 | — |
| +1 | K173180 | Mega Plus Spine System | Bk Meditech, Co., Ltd. | 2018 | — |
| +4 | K231694 | MASADA Modular Spinal Fixation System | Astura Medical | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 4 | 0 |
| 2004 | 4 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 6 | 0 |
| 2018 | 3 | 0 |
| 2020 | 3 | 0 |
| 2023 | 2 | 0 |
| 2025 | 3 | 0 |
| 2026 | 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? (4)
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 |
|---|---|---|---|
| * | K042673 | Zodiac Polyaxial Spinal Fixation SystemSummary page 1…. Predicate or legally marketed devices which are substantially equivalent: Renovis S 100 Pedicle Screw System - ZODIAC M Polyaxial Spinal Fixation - K042673 (Alphatec Spine Co) Xia3 - K071371 & K083393 (Stryker Spine) 4. Description of the device: As a posterior ped… | 2004 |
| * | K071371 | Copa Amd Antimicrobial Wound DressingSummary page 1…ich are substantially equivalent: Renovis S 100 Pedicle Screw System - ZODIAC M Polyaxial Spinal Fixation - K042673 (Alphatec Spine Co) Xia3 - K071371 & K083393 (Stryker Spine) 4. Description of the device: As a posterior pedicle screw system designed for temporary sta… | 2007 |
| * | K083393 | Xia 3 Spinal SystemSummary page 1…bstantially equivalent: Renovis S 100 Pedicle Screw System - ZODIAC M Polyaxial Spinal Fixation - K042673 (Alphatec Spine Co) Xia3 - K071371 & K083393 (Stryker Spine) 4. Description of the device: As a posterior pedicle screw system designed for temporary stabilization… | 2009 |
| * | — | Renovis S 100 Pedicle Screw System Named without a submission number |
What descends from it? (19)
See all 197 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 17 years and passes through 3 companies; a new generation was cleared every 1.3 years on median.
- 6 of the 25 ancestors have a recall of any class.
- Of its descendants, K162764 (Implanet, S.A., 2017) has gone furthest, with 6 descendants of its own.
- 12 other devices also cite its predicate K042673.
How does its category compare?
All MNH devicesMNH Orthosis, Spondylolisthesis Spinal Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 Renovis S 100 Pedlicle 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 and chronic instabilities or deformities of thoracic, lumbar, and sacral spine: failed previous fusion (pseudoarthrosis), spinal stenosis, degenerative spondylolisthesis with objective evidence of neurological impairment, spinal deformations such as…
Read the full statement (141 words)
The Renovis S 100 Pedlicle 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 and chronic instabilities or deformities of thoracic, lumbar, and sacral spine: failed previous fusion (pseudoarthrosis), spinal stenosis, degenerative spondylolisthesis with objective evidence of neurological impairment, spinal deformations such as scoliosis or kyphosis and loss of stability due to tumors or trauma (fracture and dislocation).
When used as a pedicle screw system, the Renovis S 100 Pedicle Screw System is intended for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebrae in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111940 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111940: S 100 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/K111940
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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