510(k) Report

510(k) · Cleared

Cleared

Reliance Spinal Screw System

K081978510(k) TraditionalCleared Mar 26, 2009258-day reviewClass II21 CFR 888.3070

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Reliance Medical Systems, LLC · MNI Orthosis, Spinal Pedicle Fixation

Cleared on Mar 26, 2009 as substantially equivalent to K880215 (Warsaw Orthopedic, Inc., 1988) and 24 other predicates after a 258-day review. Its family tree reaches back 10 generations to 1985. 8 later devices descend from it.

Decided
Mar 26, 2009
Review
258 days
Class
Class II
Product code
MNI
Recalls
None
Predicates
25

Its longest line of descent runs back 10 generations to K853033 (1985). 141 ancestors in all, the oldest K841189 (1984). 8 later devices descend from it, 6 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2008: 5 other ancestors2007: 10 other ancestors2006: 7 other ancestors2005: 16 other ancestors2004: 17 other ancestors2003: 8 other ancestors2002: 11 other ancestors1999: 9 other ancestors1996: 6 other ancestors1995: 6 other ancestors1994: 1 other ancestor1991: 1 other ancestor1988: 1 other ancestor2001: 11 other ancestors2000: 11 other ancestors1998: 8 other ancestors1997: 2 other ancestors1984: 1 other ancestor2012: 1 descendant cleared2016: 1 descendant cleared2013: 1 descendant cleared2022: 1 descendant cleared2010: 1 descendant cleared2015: 1 descendant cleared2021: 1 descendant cleared2023: 1 descendant clearedK853033 · Hartshill Rect & Wires, Spinal Fixation System · A.W. Showell (Surgicraft), Ltd. · 1985K965221 · Ransford Cervical Fixation System · Surgicraft, Ltd. · 1997K982322 · Synthes Spine Occipital-Cervical Plate/Rod and Hook System · Synthes (Usa) · 1998K002733 · Summit Occipito-Cervico-Thoracic (Oct) Spinal System · Depuyacromed · 2000K013222 · Summit Occipito-Cervico- Thoracic (Oct) Spinal System · Depuyacromed · 2001K022190 · Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System · Depuyacromed · 2002K030103 · Summit Oct Spinal System Minipolyaxial Screws · Depuyacromed · 2003K041203 · Summit Oct Spinal System · Depuy Spine, Inc. · 2004K062174 · Modification to Expedium Spine System · Depuy Spine, Inc. · 2006K073562 · Modification to Viper Spine System · Depuy Spine, Inc. · 200819801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 24 other ancestors2 generations back: 37 other ancestors3 generations back: 39 other ancestors4 generations back: 16 other ancestors5 generations back: 13 other ancestors6 generations back: 2 other ancestors 1 generation forward: 6 descendants2 generations forward: 2 descendants K073562 · Modification to Viper Spine System · Depuy Spine, Inc. · 2008K062174 · Modification to Expedium Spine System · Depuy Spine, Inc. · 2006K041203 · Summit Oct Spinal System · Depuy Spine, Inc. · 2004K030103 · Summit Oct Spinal System Minipolyaxial Screws · Depuyacromed · 2003K022190 · Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System · Depuyacromed · 2002K013222 · Summit Occipito-Cervico- Thoracic (Oct) Spinal System · Depuyacromed · 2001K002733 · Summit Occipito-Cervico-Thoracic (Oct) Spinal System · Depuyacromed · 2000K982322 · Synthes Spine Occipital-Cervical Plate/Rod and Hook System · Synthes (Usa) · 1998K965221 · Ransford Cervical Fixation System · Surgicraft, Ltd. · 1997K853033 · Hartshill Rect & Wires, Spinal Fixation System · A.W. Showell (Surgicraft), Ltd. · 1985−10−50
  1. Root · 10 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
  2. 6 generations between
  3. 3 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
  4. 2 generations backK062174 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
  5. 1 generation backK073562 Modification to Viper Spine SystemDepuy Spine, Inc. · 2008
  6. This deviceK081978 Reliance Spinal Screw SystemReliance Medical Systems, LLC · 2009
  7. Descendant · cites it directly · 7 of its ownK101112 Reliance Spinal Screw SystemReliance Medical Systems · 2010
  8. Descendant · cites it directly · 5 of its ownK123521 Reliance Spinal Screw SystemReliance Medical Systems, LLC · 2013
  9. Descendant · cites it directly · 5 of its ownK110896 Reliance Spinal Screw SystemReliance Medical Systems, LLC · 2012
  10. Descendant · cites it directly · 4 of its ownK152131 Reliance Spinal Screw SystemReliance Medical Systems, LLC · 2015
  11. Descendant · cites it directly · 3 of its ownK162066 Reliance Spinal Screw SystemReliance Medical Systems, LLC · 2016
Show all 10 generations
  1. Root · 10 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
  2. 9 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
  3. 8 generations backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
  4. 7 generations backK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
  5. 6 generations backK013222 Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed · 2001
  6. 5 generations backK022190 Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2002
  7. 4 generations backK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
  8. 3 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
  9. 2 generations backK062174 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
  10. 1 generation backK073562 Modification to Viper Spine SystemDepuy Spine, Inc. · 2008
  11. This deviceK081978 Reliance Spinal Screw SystemReliance Medical Systems, LLC · 2009

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2010: 12012: 12013: 12015: 12016: 12021: 12022: 12023: 1
2010high 1 (2010) · low 0 (2011)2026

Most influential descendants

Showing 5 of 8 · See all
  • K101112Reliance Spinal Screw SystemReliance Medical Systems · 2010 · cites it directly7descendants
  • K123521Reliance Spinal Screw SystemReliance Medical Systems, LLC · 2013 · cites it directly5descendants
  • K110896Reliance Spinal Screw SystemReliance Medical Systems, LLC · 2012 · cites it directly5descendants
  • K152131Reliance Spinal Screw SystemReliance Medical Systems, LLC · 2015 · cites it directly4descendants
  • K162066Reliance Spinal Screw SystemReliance Medical Systems, LLC · 2016 · cites it directly3descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−10K853033Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd.1985—
−9K965221Ransford Cervical Fixation SystemSurgicraft, Ltd.1997—
−8K982322Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa)1998—
−7K002733Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed2000—
−6K013222Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed2001—
−5K022190Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed2002—
−4K030103Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed2003—
−3K041203Summit Oct Spinal SystemDepuy Spine, Inc.2004—
−2K062174Modification to Expedium Spine SystemDepuy Spine, Inc.2006—
−1K073562Modification to Viper Spine SystemDepuy Spine, Inc.2008—
0 (this device)K081978Reliance Spinal Screw SystemReliance Medical Systems, LLC2009—
+1K101112Reliance Spinal Screw SystemReliance Medical Systems2010—
+1K123521Reliance Spinal Screw SystemReliance Medical Systems, LLC2013—
+1K110896Reliance Spinal Screw SystemReliance Medical Systems, LLC2012—
+1K152131Reliance Spinal Screw SystemReliance Medical Systems, LLC2015—
+1K162066Reliance Spinal Screw SystemReliance Medical Systems, LLC2016—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198410
198810
199110
199410
199560
199660
199720
199880
199990
2000110
2001110
2002110
200380
2004170
2005160
200670
2007100
200850

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201010
201210
201310
201510
201610
202110
202210
202310
FIG. 1 — Lineage of K081978, 1985–2023Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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
Get a 510(k) Report

What was it cleared against? (25)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K880215TSRH H/M Hook, Eyebolt/Lock Nut Assem., Spinal Rod
Summary page 1
…, MNI Substantial Equivalence The Reliance Spinal Screw is substantially equivalent to the legally marketed Medtronic TSRHT Spinal System (K8802 15, K072429), Medtronic CD Horizon (K96 1633, K063670), DePuy Expediumn Spine System (KO41 119, K08 1252), DePuy Isola Spi…
Warsaw Orthopedic, Inc.1988—
*K072429Modification to TSRH Spinal System
Summary page 1
…Substantial Equivalence The Reliance Spinal Screw is substantially equivalent to the legally marketed Medtronic TSRHT Spinal System (K8802 15, K072429), Medtronic CD Horizon (K96 1633, K063670), DePuy Expediumn Spine System (KO41 119, K08 1252), DePuy Isola Spinal…
Medtronic Sofamor Danek2007—
*K961633CD Horizon Spinal System
Summary page 1
…The Reliance Spinal Screw is substantially equivalent to the legally marketed Medtronic TSRHT Spinal System (K8802 15, K072429), Medtronic CD Horizon (K96 1633, K063670), DePuy Expediumn Spine System (KO41 119, K08 1252), DePuy Isola Spinal System (K905 184, K022285),…
Sofamor Danek USA,Inc.1996—
*K063670Modifications to CD Horizon Spinal System
Summary page 1
…e Spinal Screw is substantially equivalent to the legally marketed Medtronic TSRHT Spinal System (K8802 15, K072429), Medtronic CD Horizon (K96 1633, K063670), DePuy Expediumn Spine System (KO41 119, K08 1252), DePuy Isola Spinal System (K905 184, K022285), DePuy Viper Spine S…
Medtronic Sofamor Danek2007—
*K041119Expedium Spine SystemDepuy Spine, Inc.2004—
*K081252Expedium 4.5MM Spine System
Summary page 1
…legally marketed Medtronic TSRHT Spinal System (K8802 15, K072429), Medtronic CD Horizon (K96 1633, K063670), DePuy Expediumn Spine System (KO41 119, K08 1252), DePuy Isola Spinal System (K905 184, K022285), DePuy Viper Spine System (K061520, K073562), DePuy MOSS Miam…
Depuy Spine, Inc.2008—
*K905184Isola (TM) Spine System Top Entry Hook
Summary page 1
…l System (K8802 15, K072429), Medtronic CD Horizon (K96 1633, K063670), DePuy Expediumn Spine System (KO41 119, K08 1252), DePuy Isola Spinal System (K905 184, K022285), DePuy Viper Spine System (K061520, K073562), DePuy MOSS Miami Spinal System (K933881, K030383), Pioneer Surg…
Acromed Corp.1991—
*K022285Modification to Isola Spinal System
Summary page 1
…K8802 15, K072429), Medtronic CD Horizon (K96 1633, K063670), DePuy Expediumn Spine System (KO41 119, K08 1252), DePuy Isola Spinal System (K905 184, K022285), DePuy Viper Spine System (K061520, K073562), DePuy MOSS Miami Spinal System (K933881, K030383), Pioneer Surgical Quan…
Depuyacromed2002—
*K061520Viper Spine System
Summary page 1
…izon (K96 1633, K063670), DePuy Expediumn Spine System (KO41 119, K08 1252), DePuy Isola Spinal System (K905 184, K022285), DePuy Viper Spine System (K061520, K073562), DePuy MOSS Miami Spinal System (K933881, K030383), Pioneer Surgical Quantum Spinal System (K070973…
Depuy Spine, Inc.2006—
*K073562Modification to Viper Spine System
Summary page 1
…1633, K063670), DePuy Expediumn Spine System (KO41 119, K08 1252), DePuy Isola Spinal System (K905 184, K022285), DePuy Viper Spine System (K061520, K073562), DePuy MOSS Miami Spinal System (K933881, K030383), Pioneer Surgical Quantum Spinal System (K070973, K0805 1…
Depuy Spine, Inc.2008—
*K933881Depuy Motech Moss-Miami Spinal System
Summary page 1
…tem (KO41 119, K08 1252), DePuy Isola Spinal System (K905 184, K022285), DePuy Viper Spine System (K061520, K073562), DePuy MOSS Miami Spinal System (K933881, K030383), Pioneer Surgical Quantum Spinal System (K070973, K0805 18), K2M Range Spinal System (K080792), K2M Denali…
Depuy, Inc.1994—
*K030383Modification to Moss Miami Spinal System Polyaxial Screws
Summary page 1
…119, K08 1252), DePuy Isola Spinal System (K905 184, K022285), DePuy Viper Spine System (K061520, K073562), DePuy MOSS Miami Spinal System (K933881, K030383), Pioneer Surgical Quantum Spinal System (K070973, K0805 18), K2M Range Spinal System (K080792), K2M Denali S…
Depuyacromed2003—
*K070973Quantum Spinal System
Summary page 1
…84, K022285), DePuy Viper Spine System (K061520, K073562), DePuy MOSS Miami Spinal System (K933881, K030383), Pioneer Surgical Quantum Spinal System (K070973, K0805 18), K2M Range Spinal System (K080792), K2M Denali Spinal System (K042635, K052404), K2M Mesa Spinal System (K05…
Pioneer Surgical Technology2007—
*K080518Pioneer Surgical Technology Quantum Spinal System
Summary page 1
…85), DePuy Viper Spine System (K061520, K073562), DePuy MOSS Miami Spinal System (K933881, K030383), Pioneer Surgical Quantum Spinal System (K070973, K0805 18), K2M Range Spinal System (K080792), K2M Denali Spinal System (K042635, K052404), K2M Mesa Spinal System (K052398), Int…
Pioneer Surgical Technology2008—
*K080792K2M Cocr Rod
Summary page 1
…20, K073562), DePuy MOSS Miami Spinal System (K933881, K030383), Pioneer Surgical Quantum Spinal System (K070973, K0805 18), K2M Range Spinal System (K080792), K2M Denali Spinal System (K042635, K052404), K2M Mesa Spinal System (K052398), Inter-pore Cross Synergy Spi…
K2m, Inc.2008—
*K042635Denali Spine System
Summary page 1
…l System (K933881, K030383), Pioneer Surgical Quantum Spinal System (K070973, K0805 18), K2M Range Spinal System (K080792), K2M Denali Spinal System (K042635, K052404), K2M Mesa Spinal System (K052398), Inter-pore Cross Synergy Spinal System (K94063 1, K04 1449), Stryker Xia S…
K2m, LLC2005—
*K052404Denali Deformity System
Summary page 1
…(K933881, K030383), Pioneer Surgical Quantum Spinal System (K070973, K0805 18), K2M Range Spinal System (K080792), K2M Denali Spinal System (K042635, K052404), K2M Mesa Spinal System (K052398), Inter-pore Cross Synergy Spinal System (K94063 1, K04 1449), Stryker Xia Spinal Sys…
K2m, LLC2006—
*K052398Mesa Spinal System
Summary page 1
…al Quantum Spinal System (K070973, K0805 18), K2M Range Spinal System (K080792), K2M Denali Spinal System (K042635, K052404), K2M Mesa Spinal System (K052398), Inter-pore Cross Synergy Spinal System (K94063 1, K04 1449), Stryker Xia Spinal System (K98425 1, K080928),…
K2m, LLC2005—
*K940631Cross Medical - Synergy (TM) Spine System
Summary page 1
…Range Spinal System (K080792), K2M Denali Spinal System (K042635, K052404), K2M Mesa Spinal System (K052398), Inter-pore Cross Synergy Spinal System (K94063 1, K04 1449), Stryker Xia Spinal System (K98425 1, K080928), X-Spine Capless Pedicle Screw System (K052847, K072282),…
Cross Medical Products, Inc.1995—
*K041449Synergy Helical Flange Plug, Helical Flange Seat and Helical Flange Reduction Seat
Summary page 1
…al System (K080792), K2M Denali Spinal System (K042635, K052404), K2M Mesa Spinal System (K052398), Inter-pore Cross Synergy Spinal System (K94063 1, K04 1449), Stryker Xia Spinal System (K98425 1, K080928), X-Spine Capless Pedicle Screw System (K052847, K072282), Syn…
Interpore Cross Intl.2004—
*K984251Xia Spine System
Summary page 1
…System (K042635, K052404), K2M Mesa Spinal System (K052398), Inter-pore Cross Synergy Spinal System (K94063 1, K04 1449), Stryker Xia Spinal System (K98425 1, K080928), X-Spine Capless Pedicle Screw System (K052847, K072282), Synthes Pangea (K052 123). The Reliance Spinal Scre…
Howmedica, Inc.1999—
*K080928Xia Spinal System, Stainless Steel Uni-Planar Screws
Summary page 1
…042635, K052404), K2M Mesa Spinal System (K052398), Inter-pore Cross Synergy Spinal System (K94063 1, K04 1449), Stryker Xia Spinal System (K98425 1, K080928), X-Spine Capless Pedicle Screw System (K052847, K072282), Synthes Pangea (K052 123). The Reliance Spinal Screw is equi…
Stryker Spine2008—
*K052847Capless Pedicle Screw System
Summary page 1
…8), Inter-pore Cross Synergy Spinal System (K94063 1, K04 1449), Stryker Xia Spinal System (K98425 1, K080928), X-Spine Capless Pedicle Screw System (K052847, K072282), Synthes Pangea (K052 123). The Reliance Spinal Screw is equivalent to these commercially available…
X-Spine Systems, Inc.2005—
*K072282Capless LI Pedicle Screw System
Summary page 1
…-pore Cross Synergy Spinal System (K94063 1, K04 1449), Stryker Xia Spinal System (K98425 1, K080928), X-Spine Capless Pedicle Screw System (K052847, K072282), Synthes Pangea (K052 123). The Reliance Spinal Screw is equivalent to these commercially available devices…
X-Spine Systems, Inc.20071
*K052123Synthes Pangea System
Summary page 1
…System (K94063 1, K04 1449), Stryker Xia Spinal System (K98425 1, K080928), X-Spine Capless Pedicle Screw System (K052847, K072282), Synthes Pangea (K052 123). The Reliance Spinal Screw is equivalent to these commercially available devices in terms of material, intended use, l…
Synthes (Usa)2005—

Also cleared against K880215: 2 other devices →

What descends from it? (8)

6 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K101112Reliance Spinal Screw SystemReliance Medical Systems20107
K123521Reliance Spinal Screw SystemReliance Medical Systems, LLC20135
K110896Reliance Spinal Screw SystemReliance Medical Systems, LLC20125
K152131Reliance Spinal Screw SystemReliance Medical Systems, LLC20154
K162066Reliance Spinal Screw SystemReliance Medical Systems, LLC20163
K213750VyLink™ Spinal Screw SystemVy Spine, LLC20221

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 24 years and passes through 6 companies; a new generation was cleared every 1.3 years on median.
  • 11 of the 141 ancestors have a recall of any class.
  • Of its descendants, K101112 (Reliance Medical Systems, 2010) has gone furthest, with 7 descendants of its own.
  • 2 other devices also cite its predicate K880215.

How does its category compare?

All MNI devices

MNI Orthosis, Spinal Pedicle Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · MNI

1in 2017

2007: 202008: 232009: 182010: 162011: 172012: 192013: 142014: 62015: 122016: 72017: 1
2007high 23 (2008) · low 0 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MNI

168in 2016

2007: 82 days median2008: 64 days median2009: 86 days median2010: 74 days median2011: 111 days median2012: 75 days median2013: 77 days median2014: 104 days median2015: 54 days median2016: 168 days median
2007high 168 (2016) · low 54 (2015)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MNI

1in 2018

2007: 262008: 82009: 32010: 12012: 12013: 42015: 12018: 1
2007high 26 (2007) · low 0 (2011)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MNI

80in 2025

2007: 832008: 1082009: 1382010: 1262011: 1462012: 2002013: 8242014: 3012015: 2602016: 1172017: 2472018: 1342019: 1882020: 1152021: 2702022: 2142023: 1222024: 1142025: 80
2007high 824 (2013) · low 80 (2025)2025

MAUDE reports naming product code MNI, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200720822683
200823648108
200918863138
201016741126
2011171110146
201219751200
201314774824
201461040301
201512541260
201671680117
20171—0247
20180—1134
20190—0188
20200—0115
20210—0270
20220—0214
20230—0122
20240—0114
20250—080
20260—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 (271 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 spondylolisthesis (Grades 3 and 4) of the L5-S 1 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 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 anterior 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: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.

Also cleared against K880215

2 other devices cite the same predicate.

  • K110896Reliance Spinal Screw SystemReliance Medical Systems, LLC · 2012
  • K101112Reliance Spinal Screw SystemReliance Medical Systems · 2010

More from Reliance Medical Systems, LLC

24 FDA decisions under this applicant name. See the company

  • K202266Reliance Cervical IBF SystemReliance Medical Systems, LLC · 2022
  • K210874Reliance Spinal Screw SystemReliance Medical Systems, LLC · 2021
  • K183049Reliance Lumbar IBF SystemReliance Medical Systems, LLC · 2019
  • K173283Reliance Lumbar IBF SystemReliance Medical Systems, LLC · 2018
  • K173102Reliance Cervical IBF SystemReliance Medical Systems, LLC · 2017

Recent decisions in MNI

The MNI category page

  • K171497Mikron Spinal Fixation SystemMikron Makina Sanayi Ticaret Co., Ltd. · 2017
  • K160731LumFix Spinal Fixation SytemCG Bio Co., Ltd. · 2016
  • K151458Double Medical Universal Spine SystemDouble Medical Technology, Inc. · 2016
  • K153273MySpine Pedicle Screw Placement Guides - LPMedacta International S.A. · 2016
  • K160124LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation SystemSpinevision S.A. · 2016

https://510kreport.com/device/K081978 · printed Nov 3, 2026

Cite this page

510(k) Report. “K081978: Reliance Spinal Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K081978

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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