510(k) · Cleared
ClearedSynfix -LR
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synthes Spine Co.Lp · MQP Spinal Vertebral Body Replacement Device
Cleared on Apr 3, 2007 as substantially equivalent to K011037 (Synthes (Usa), 2002) and 1 other predicate after a 256-day review. Its family tree reaches back 1 generation to 2001. 1 of the 1,255 devices in its family, counting itself, has a Class I recall. 1,252 later devices descend from it.
- Decided
- Apr 3, 2007
- Review
- 256 days
- Class
- Class II
- Product code
- MQP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K010530 (2001). 2 ancestors in all. 1,252 later devices descend from it, 6 citing it directly. 1 of the 1,255 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK010530 Geo StructureInterpore Cross Intl. · 2001
- This deviceK062083 Synfix -LRSynthes Spine Co.Lp · 2007
- Descendant · cites it directly · 1,250 of its ownK072253 Synfix-LR SpacerSynthes Spine Co.Lp · 2007 · Recalled
- Descendant · 2 generations on · 1,102 of its ownK073470 Avs PL Peek Spacers, Models 48351XXX and 48353XXXStryker Spine · 2008
- Descendant · 3 generations on · 1,091 of its ownK080758 Avs PL Peek Spacers, Models 48351 and 48353Stryker Corp. · 2008
- Descendant · 2 generations on · 932 of its ownK080083 Intrepid Spinal SystemMedtronic Sofamor Danek · 2008 · Recalled
- Descendant · 3 generations on · 907 of its ownK073109 Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd. · 2008
Showing 5 of 1,252 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub7 generations on · 2021
Most influential descendants
Showing 5 of 1,252 · See all- K072253Synfix-LR SpacerSynthes Spine Co.Lp · 2007 · cites it directly1,250descendants
- K073470Avs PL Peek Spacers, Models 48351XXX and 48353XXXStryker Spine · 2008 · 2 generations on1,102descendants
- K080758Avs PL Peek Spacers, Models 48351 and 48353Stryker Corp. · 2008 · 3 generations on1,091descendants
- K080083Intrepid Spinal SystemMedtronic Sofamor Danek · 2008 · 2 generations on932descendants
- K073109Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd. · 2008 · 3 generations on907descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K010530 | Geo Structure | Interpore Cross Intl. | 2001 | — |
| 0 (this device) | K062083 | Synfix -LR | Synthes Spine Co.Lp | 2007 | — |
| +1 | K072253 | Synfix-LR Spacer | Synthes Spine Co.Lp | 2007 | 1 |
| +2 | K073470 | Avs PL Peek Spacers, Models 48351XXX and 48353XXX | Stryker Spine | 2008 | — |
| +3 | K080758 | Avs PL Peek Spacers, Models 48351 and 48353 | Stryker Corp. | 2008 | — |
| +2 | K080083 | Intrepid Spinal System | Medtronic Sofamor Danek | 2008 | 8 |
| +3 | K073109 | Stalif TT Intervertebral Body Fusion System | Surgicraft, Ltd. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 2 | 0 |
| 2008 | 13 | 0 |
| 2009 | 13 | 0 |
| 2010 | 21 | 0 |
| 2011 | 28 | 0 |
| 2012 | 28 | 0 |
| 2013 | 29 | 0 |
| 2014 | 51 | 0 |
| 2015 | 53 | 0 |
| 2016 | 81 | 0 |
| 2017 | 100 | 0 |
| 2018 | 100 | 0 |
| 2019 | 93 | 0 |
| 2020 | 97 | 0 |
| 2021 | 89 | 1 |
| 2022 | 84 | 0 |
| 2023 | 104 | 0 |
| 2024 | 106 | 0 |
| 2025 | 83 | 0 |
| 2026 | 77 | 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.
1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MQP device
- #1 K261810 Vertiwedge® Intraosseous Systemscore 18.1 · 22 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K011037 | Vertebral SpacerSummary page 1…vice Product MQP Code and 21 CER 888.3060 Classification: Class II Predicates: K01 1037 - Synthes Vertebral Spacer K010530 - Interpore Cross Georm Structure Device D… | 2002 |
| * | K010530 | Geo StructureSummary page 1…88.3060 Classification: Class II Predicates: K01 1037 - Synthes Vertebral Spacer K010530 - Interpore Cross Georm Structure Device Description: The Synthes SynflxTm-LR is a combination radiolucent and… | 2001 |
What descends from it? (1,252)
See all 1,2526 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 7 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
How does its category compare?
All MQP devicesMQP Spinal Vertebral Body Replacement Device: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · MQP
4in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · MQP
187in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MQP
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MQP
168in 2025
MAUDE reports naming product code MQP, 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 | 30 | 107 | 2 | 61 |
| 2008 | 17 | 47 | 0 | 76 |
| 2009 | 11 | 115 | 14 | 111 |
| 2010 | 6 | 174 | 2 | 166 |
| 2011 | 8 | 237 | 1 | 121 |
| 2012 | 7 | 82 | 2 | 141 |
| 2013 | 3 | 90 | 0 | 207 |
| 2014 | 5 | 125 | 0 | 216 |
| 2015 | 8 | 126 | 0 | 258 |
| 2016 | 0 | — | 0 | 129 |
| 2017 | 9 | 97 | 0 | 141 |
| 2018 | 6 | 152 | 0 | 130 |
| 2019 | 8 | 93 | 0 | 117 |
| 2020 | 3 | 103 | 15 | 157 |
| 2021 | 0 | — | 0 | 208 |
| 2022 | 1 | — | 1 | 137 |
| 2023 | 1 | — | 0 | 71 |
| 2024 | 4 | 187 | 0 | 98 |
| 2025 | 0 | — | 0 | 168 |
| 2026 | 3 | 102 | 0 | — |
What is it indicated for?
The SynFix-LR is a stand-alone vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) to replace a diseased vertebral body resected or excised during partial vertebrectomy procedures for the treatment of tumor or trauma (i.e. fracture) to achieve anterior decompression of the spinal cord and neural tissues. The interior of the spacer component of the SynFix-LR can be packed with bone (autograft or allografi).
The SynFix-LR is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062083 · printed Nov 4, 2026
Cite this page
510(k) Report. “K062083: Synfix -LR.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K062083
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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