510(k) · Cleared
ClearedConquest Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Life Spine · MNI Orthosis, Spinal Pedicle Fixation
Cleared on May 21, 2008 as substantially equivalent to K061600 (Life Spine, 2006) and 1 other predicate after a 64-day review. Its family tree reaches back 11 generations to 1985. 21 later devices descend from it.
- Decided
- May 21, 2008
- Review
- 64 days
- Class
- Class II
- Product code
- MNI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 11 generations to K853033 (1985). 141 ancestors in all. 21 later devices descend from it, 5 citing it directly.
- Root · 11 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 7 generations between
- 3 generations backK062174 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- 2 generations backK070387 Expedium Spine SystemDepuy Spine, Inc. · 2007
- 1 generation backK073430 Valeo Pedicle Screw Spinal SystemAmedica Corp. · 2008
- This deviceK080767 Conquest Spinal SystemLife Spine · 2008
- Descendant · cites it directly · 17 of its ownK123373 Nautilus Spinal SystemLife Spine · 2013
- Descendant · 2 generations on · 14 of its ownK132760 Nautilus Spinal SystemLife Spine, Inc. · 2013
- Descendant · cites it directly · 13 of its ownK141222 Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc. · 2015
- Descendant · 3 generations on · 13 of its ownK133564 Modification to Nautilus Spinal SystemLife Spine, LLC · 2014
- Descendant · 2 generations on · 12 of its ownK151196 Nautilus Spinal SystemLife Spine, Inc. · 2015
Show all 11 generations
- Root · 11 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 10 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
- 9 generations backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
- 8 generations backK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
- 7 generations backK013222 Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed · 2001
- 6 generations backK022190 Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2002
- 5 generations backK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
- 4 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
- 3 generations backK062174 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- 2 generations backK070387 Expedium Spine SystemDepuy Spine, Inc. · 2007
- 1 generation backK073430 Valeo Pedicle Screw Spinal SystemAmedica Corp. · 2008
- This deviceK080767 Conquest Spinal SystemLife Spine · 2008
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K123373Nautilus Spinal SystemLife Spine · 2013 · cites it directly17descendants
- K132760Nautilus Spinal SystemLife Spine, Inc. · 2013 · 2 generations on14descendants
- K141222Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc. · 2015 · cites it directly13descendants
- K133564Modification to Nautilus Spinal SystemLife Spine, LLC · 2014 · 3 generations on13descendants
- K151196Nautilus Spinal SystemLife Spine, Inc. · 2015 · 2 generations on12descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K853033 | Hartshill Rect & Wires, Spinal Fixation System | A.W. Showell (Surgicraft), Ltd. | 1985 | — |
| −10 | K965221 | Ransford Cervical Fixation System | Surgicraft, Ltd. | 1997 | — |
| −9 | K982322 | Synthes Spine Occipital-Cervical Plate/Rod and Hook System | Synthes (Usa) | 1998 | — |
| −8 | K002733 | Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2000 | — |
| −7 | K013222 | Summit Occipito-Cervico- Thoracic (Oct) Spinal System | Depuyacromed | 2001 | — |
| −6 | K022190 | Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2002 | — |
| −5 | K030103 | Summit Oct Spinal System Minipolyaxial Screws | Depuyacromed | 2003 | — |
| −4 | K041203 | Summit Oct Spinal System | Depuy Spine, Inc. | 2004 | — |
| −3 | K062174 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2006 | — |
| −2 | K070387 | Expedium Spine System | Depuy Spine, Inc. | 2007 | — |
| −1 | K073430 | Valeo Pedicle Screw Spinal System | Amedica Corp. | 2008 | — |
| 0 (this device) | K080767 | Conquest Spinal System | Life Spine | 2008 | — |
| +1 | K123373 | Nautilus Spinal System | Life Spine | 2013 | — |
| +2 | K132760 | Nautilus Spinal System | Life Spine, Inc. | 2013 | — |
| +1 | K141222 | Nautilus Spinal System and Solstice Oct System | Life Spine, Inc. | 2015 | — |
| +3 | K133564 | Modification to Nautilus Spinal System | Life Spine, LLC | 2014 | — |
| +2 | K151196 | Nautilus Spinal System | Life Spine, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 2 | 0 |
| 1992 | 5 | 0 |
| 1993 | 3 | 0 |
| 1994 | 3 | 0 |
| 1995 | 7 | 0 |
| 1996 | 4 | 0 |
| 1997 | 4 | 0 |
| 1998 | 11 | 0 |
| 1999 | 11 | 0 |
| 2000 | 10 | 0 |
| 2001 | 9 | 0 |
| 2002 | 8 | 0 |
| 2003 | 13 | 0 |
| 2004 | 16 | 0 |
| 2005 | 10 | 0 |
| 2006 | 6 | 0 |
| 2007 | 8 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 3 | 0 |
| 2015 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 2 | 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? (2)
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 |
|---|---|---|---|
| * | K061600 | Arx Spinal SystemSummary page 1…MNH, 21 CFR 888.3070, Class II MNI, 21 CFR 888.3070, Class II Predicate Devices: ARX Spinal System (K061600) Life Spine Cross Connector (K073430) Device Description: The CONQUEST Spinal System is… | 2006 |
| * | K073430 | Valeo Pedicle Screw Spinal SystemSummary page 1…MNI, 21 CFR 888.3070, Class II Predicate Devices: ARX Spinal System (K061600) Life Spine Cross Connector (K073430) Device Description: The CONQUEST Spinal System is a titanium alloy multiple component system comprised of a variety of non-ste… | 2008 |
What descends from it? (21)
See all 215 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 23 years and passes through 7 companies; a new generation was cleared every 11 months on median.
- 13 of the 141 ancestors have a recall of any class.
- Of its descendants, K123373 (Life Spine, 2013) has gone furthest, with 17 descendants of its own.
- 4 other devices also cite its predicate K061600.
How does its category compare?
All MNI devicesMNI Orthosis, Spinal Pedicle Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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?
Internal fixation implants are load-sharing devices intended to stabilize and maintain alignment until normal healing occurs. Implants are not intended to replace normal body structures or bear the weight of the body in the presence of incomplete bone healing. The CONQUEST Spinal System, when properly used, is intended for posterior pedicle screw fixation of the non-cervical posterior spine in skeletally mature patients. It provides stabilization and…
Read the full statement (145 words)
Internal fixation implants are load-sharing devices intended to stabilize and maintain alignment until normal healing occurs. Implants are not intended to replace normal body structures or bear the weight of the body in the presence of incomplete bone healing.
The CONQUEST Spinal System, when properly used, is intended for posterior pedicle screw fixation of the non-cervical posterior spine in skeletally mature patients. It provides stabilization and immobilization of spinal segments as an adjunct to fusion.
When used as a posterior spine thoracic/lumbar system, the CONQUEST Spinal System is indicated for one or more of the following: (1) degenerative disc disease (is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), (2) trauma (i.e. fracture or dislocation), (3) curvatures (scoliosis, kyphosis, and/or lordosis), (4) spinal tumor, (5) failed previous fusion (6) pseudarthrosis, (7) spinal stenosis, (8) spondylolisthesis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080767 · printed Nov 3, 2026
Cite this page
510(k) Report. “K080767: Conquest Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080767
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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