510(k) · Cleared
Recalled · Class II · 2013Lancer Pedicle Screw System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spinal Solutions, LLC · MNH Orthosis, Spondylolisthesis Spinal Fixation
Cleared on Dec 15, 2011 as substantially equivalent to K033826 (Orthopedic Alliance, LLC, 2004) and 1 other predicate after a 286-day review. Its family tree reaches back 4 generations to 1999. It has been recalled 8 times.
- Decided
- Dec 15, 2011
- Review
- 286 days
- Class
- Class II
- Product code
- MNH
- Recalls
- 8
- Predicates
- 2
Its longest line of descent runs back 4 generations to K990745 (1999). 15 ancestors in all, the oldest K901587 (1990). No later device cites it as a predicate yet.
- Root · 4 generations backK990745 Modification to Synthes Universal Spinal SystemSynthes Spine · 1999
- 3 generations backK992739 Click'xSynthes Spine · 2000 · Recalled
- 2 generations backK052123 Synthes Pangea SystemSynthes (Usa) · 2005
- 1 generation backK092420 KRD1 Pedicle Screw SystemSpinefrontier, Inc. · 2009 · Recalled
- This deviceK110633 Lancer Pedicle Screw SystemSpinal Solutions, LLC · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K990745 | Modification to Synthes Universal Spinal System | Synthes Spine | 1999 | — |
| −3 | K992739 | Click'x | Synthes Spine | 2000 | 1 |
| −2 | K052123 | Synthes Pangea System | Synthes (Usa) | 2005 | — |
| −1 | K092420 | KRD1 Pedicle Screw System | Spinefrontier, Inc. | 2009 | 2 |
| 0 (this device) | K110633 | Lancer Pedicle Screw System | Spinal Solutions, LLC | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 2 | 0 |
| 1992 | 5 | 0 |
| 1993 | 2 | 0 |
| 1997 | 1 | 0 |
| 2004 | 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? (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 |
|---|---|---|---|
| * | K033826 | Orthopedic Alliance Spine SystemSummary page 1…ate or legally marketed devices which are substantially equivalent: The Lancer Pedicle Screw System isa modification of the Orthopedic Alliance Spine System (K033826). Other predicate devices include: KRD-1"'- - K092420 (SpineFrontier) 4. Description of the device: The Lancer Ped… | 2004 |
| * | K092420 | KRD1 Pedicle Screw SystemSummary page 1…alent: The Lancer Pedicle Screw System isa modification of the Orthopedic Alliance Spine System (K033826). Other predicate devices include: KRD-1"'- - K092420 (SpineFrontier) 4. Description of the device: The Lancer Pedlicle Screw System is comprised of polyaxial pedicle screws,… | 2009 |
| † | K000236 | Synergy VLS Cap Nut Models 2206, 6102 | 2000 |
| † | K950697 | Depuy Motech Moss Miami Spinal System - Pedicle Fixation | 1995 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 20, 2013 | Class II | Z-1415-2013 | Labeling design | The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Spinal Solutions because the directions for use and surgical techniques were not being provided to every physician and for every surgery. |
| Feb 20, 2013 | Class II | Z-1413-2013 | Labeling design | The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Spinal Solutions because the directions for use and surgical techniques were not being provided to every physician and for every surgery. |
| Feb 20, 2013 | Class II | Z-1410-2013 | Labeling design | The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Spinal Solutions because the directions for use and surgical techniques were not being provided to every physician and for every surgery. |
| Feb 20, 2013 | Class II | Z-1412-2013 | Labeling design | The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Spinal Solutions because the directions for use and surgical techniques were not being provided to every physician and for every surgery. |
| Feb 20, 2013 | Class II | Z-1416-2013 | Labeling design | The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Spinal Solutions because the directions for use and surgical techniques were not being provided to every physician and for every surgery. |
| Feb 20, 2013 | Class II | Z-1411-2013 | Labeling design | The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Spinal Solutions because the directions for use and surgical techniques were not being provided to every physician and for every surgery. |
| Feb 20, 2013 | Class II | Z-1409-2013 | Labeling design | The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Spinal Solutions because the directions for use and surgical techniques were not being provided to every physician and for every surgery. |
| Feb 20, 2013 | Class II | Z-1414-2013 | Labeling design | The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Spinal Solutions because the directions for use and surgical techniques were not being provided to every physician and for every surgery. |
The 5 latest of 8 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 4 companies; a new generation was cleared every 4.2 years on median.
- 3 of the 15 ancestors have a recall of any class.
- 2 other devices also cite its predicate K033826.
How does its category compare?
All MNH devicesMNH Orthosis, Spondylolisthesis Spinal Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 Lancer Pedicle 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: fracture, dislocation, failed previous fusion (pseudoarthrosis), degenerative spondylolisthesis with objective evidence of neurological impairment, spinal deformations such as…
Read the full statement (132 words)
The Lancer Pedicle 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: fracture, dislocation, failed previous fusion (pseudoarthrosis), degenerative spondylolisthesis with objective evidence of neurological impairment, spinal deformations such as scoliosis or kylphosis and loss of stability due to tumors.
When used as a pedicle screw system, the Lancer Pedlicle Screw System is intended for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L_5-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/K110633 · printed Nov 4, 2026
Cite this page
510(k) Report. “K110633: Lancer Pedicle Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K110633
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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