510(k) · Cleared
ClearedReliance Spinal Screw System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Reliance Medical Systems, LLC · MNI Orthosis, Spinal Pedicle Fixation
Cleared on Feb 7, 2013 as substantially equivalent to K081978 (Reliance Medical Systems, LLC, 2009) and 2 other predicates after an 84-day review. Its family tree reaches back 12 generations to 1985. 5 later devices descend from it.
- Decided
- Feb 7, 2013
- Review
- 84 days
- Class
- Class II
- Product code
- MNI
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 12 generations to K853033 (1985). 146 ancestors in all, the oldest K841189 (1984). 5 later devices descend from it, 3 citing it directly.
- Root · 12 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 8 generations between
- 3 generations backK073562 Modification to Viper Spine SystemDepuy Spine, Inc. · 2008
- 2 generations backK081978 Reliance Spinal Screw SystemReliance Medical Systems, LLC · 2009
- 1 generation backK101112 Reliance Spinal Screw SystemReliance Medical Systems · 2010
- This deviceK123521 Reliance Spinal Screw SystemReliance Medical Systems, LLC · 2013
- Descendant · cites it directly · 4 of its ownK152131 Reliance Spinal Screw SystemReliance Medical Systems, LLC · 2015
- Descendant · cites it directly · 3 of its ownK162066 Reliance Spinal Screw SystemReliance Medical Systems, LLC · 2016
- Descendant · 2 generations on · 2 of its ownK210874 Reliance Spinal Screw SystemReliance Medical Systems, LLC · 2021
- Descendant · cites it directly · 1 of its ownK213750 VyLink™ Spinal Screw SystemVy Spine, LLC · 2022
- Descendant · 2 generations on · 0 of its ownK231744 VyLink™ Spinal Screw SystemVy Spine, LLC · 2023
Show all 12 generations
- Root · 12 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 11 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
- 10 generations backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
- 9 generations backK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
- 8 generations backK013222 Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed · 2001
- 7 generations backK022190 Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2002
- 6 generations backK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
- 5 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
- 4 generations backK062174 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- 3 generations backK073562 Modification to Viper Spine SystemDepuy Spine, Inc. · 2008
- 2 generations backK081978 Reliance Spinal Screw SystemReliance Medical Systems, LLC · 2009
- 1 generation backK101112 Reliance Spinal Screw SystemReliance Medical Systems · 2010
- This deviceK123521 Reliance Spinal Screw SystemReliance Medical Systems, LLC · 2013
Most influential descendants
Showing 5 of 5 · See all- K152131Reliance Spinal Screw SystemReliance Medical Systems, LLC · 2015 · cites it directly4descendants
- K162066Reliance Spinal Screw SystemReliance Medical Systems, LLC · 2016 · cites it directly3descendants
- K210874Reliance Spinal Screw SystemReliance Medical Systems, LLC · 2021 · 2 generations on2descendants
- K213750VyLink™ Spinal Screw SystemVy Spine, LLC · 2022 · cites it directly1descendant
- K231744VyLink™ Spinal Screw SystemVy Spine, LLC · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K853033 | Hartshill Rect & Wires, Spinal Fixation System | A.W. Showell (Surgicraft), Ltd. | 1985 | — |
| −11 | K965221 | Ransford Cervical Fixation System | Surgicraft, Ltd. | 1997 | — |
| −10 | K982322 | Synthes Spine Occipital-Cervical Plate/Rod and Hook System | Synthes (Usa) | 1998 | — |
| −9 | K002733 | Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2000 | — |
| −8 | K013222 | Summit Occipito-Cervico- Thoracic (Oct) Spinal System | Depuyacromed | 2001 | — |
| −7 | K022190 | Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2002 | — |
| −6 | K030103 | Summit Oct Spinal System Minipolyaxial Screws | Depuyacromed | 2003 | — |
| −5 | K041203 | Summit Oct Spinal System | Depuy Spine, Inc. | 2004 | — |
| −4 | K062174 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2006 | — |
| −3 | K073562 | Modification to Viper Spine System | Depuy Spine, Inc. | 2008 | — |
| −2 | K081978 | Reliance Spinal Screw System | Reliance Medical Systems, LLC | 2009 | — |
| −1 | K101112 | Reliance Spinal Screw System | Reliance Medical Systems | 2010 | — |
| 0 (this device) | K123521 | Reliance Spinal Screw System | Reliance Medical Systems, LLC | 2013 | — |
| +1 | K152131 | Reliance Spinal Screw System | Reliance Medical Systems, LLC | 2015 | — |
| +1 | K162066 | Reliance Spinal Screw System | Reliance Medical Systems, LLC | 2016 | — |
| +2 | K210874 | Reliance Spinal Screw System | Reliance Medical Systems, LLC | 2021 | — |
| +1 | K213750 | VyLink™ Spinal Screw System | Vy Spine, LLC | 2022 | — |
| +2 | K231744 | VyLink™ Spinal Screw System | Vy Spine, LLC | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1988 | 1 | 0 |
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 6 | 0 |
| 1996 | 6 | 0 |
| 1997 | 2 | 0 |
| 1998 | 8 | 0 |
| 1999 | 9 | 0 |
| 2000 | 11 | 0 |
| 2001 | 11 | 0 |
| 2002 | 11 | 0 |
| 2003 | 8 | 0 |
| 2004 | 17 | 0 |
| 2005 | 16 | 0 |
| 2006 | 8 | 0 |
| 2007 | 10 | 0 |
| 2008 | 5 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 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 MNI? 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K081978 | Reliance Spinal Screw SystemSummary page 1…KWP, KWQ, MNH, MN! Substantial Equivalence The Reliance Spinal Screw is substantially equivalent to the legally marketed Reliance Spinal Screw (K081978, KIOI 112, and KI f6896) and the Nuvasive SpherX (K102514). The Reliance Spinal Screw is equivalent to these commercially availab… | 2009 |
| * | K101112 | Reliance Spinal Screw System | 2010 |
| Kept off the family tree | K116896 | Reliance Spinal Screw Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | |
| * | K102514 | Nuvasive Spherx II -Mas Deformity Spinal SystemSummary page 1…quivalence The Reliance Spinal Screw is substantially equivalent to the legally marketed Reliance Spinal Screw (K081978, KIOI 112, and KI f6896) and the Nuvasive SpherX (K102514). The Reliance Spinal Screw is equivalent to these commercially available devices in terms of material, intended use, levels of a… | 2010 |
What descends from it? (5)
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)
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 28 years and passes through 7 companies; a new generation was cleared every 1.5 years on median.
- 11 of the 146 ancestors have a recall of any class.
- Of its descendants, K152131 (Reliance Medical Systems, LLC, 2015) has gone furthest, with 4 descendants of its own.
- 5 other devices also cite its predicate K081978.
How does its category compare?
All MNI devicesMNI Orthosis, Spinal Pedicle Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · MNI
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · MNI
168in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MNI
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MNI
80in 2025
MAUDE reports naming product code MNI, 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 | 20 | 82 | 26 | 83 |
| 2008 | 23 | 64 | 8 | 108 |
| 2009 | 18 | 86 | 3 | 138 |
| 2010 | 16 | 74 | 1 | 126 |
| 2011 | 17 | 111 | 0 | 146 |
| 2012 | 19 | 75 | 1 | 200 |
| 2013 | 14 | 77 | 4 | 824 |
| 2014 | 6 | 104 | 0 | 301 |
| 2015 | 12 | 54 | 1 | 260 |
| 2016 | 7 | 168 | 0 | 117 |
| 2017 | 1 | — | 0 | 247 |
| 2018 | 0 | — | 1 | 134 |
| 2019 | 0 | — | 0 | 188 |
| 2020 | 0 | — | 0 | 115 |
| 2021 | 0 | — | 0 | 270 |
| 2022 | 0 | — | 0 | 214 |
| 2023 | 0 | — | 0 | 122 |
| 2024 | 0 | — | 0 | 114 |
| 2025 | 0 | — | 0 | 80 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Reliance Spinal Screw System is a pedicle screw systems 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 the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and…
Read the full statement (275 words)
The Reliance Spinal Screw System is a pedicle screw systems 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 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). The Reliance Spinal Screw System is also indicated for pedicle screw fixation for the treatment of severe degenerative spondylolisthesis (Grades 3 and 4) of the L5-S I vertebra 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.
When used posteriorly, the Reliance Spinal Screw System is also a hook and sacral/iliac screw fixation system of the noncervical spine indicated for degenerative spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudarthrosis). Levels of fixation are for the thoracic, lumbar and sacral spine.
The Reliance Spinal Screw System when used with staples and two rods as an anterioi thoracic/lumbar screw fixation system, is indicated for spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudarthrosis).
When used in a percutaneous, posterior approach with MIS Instrumentation, the Reliance Spinal Screw System components are intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123521 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123521: Reliance Spinal 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/K123521
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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