510(k) · Cleared
Recalled · 2010Synfix-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 Feb 13, 2006 as substantially equivalent to K011037 (Synthes (Usa), 2002) and 1 other predicate after a 59-day review. Its family tree reaches back 8 generations to 2001. 39 later devices descend from it. It has been recalled once.
- Decided
- Feb 13, 2006
- Review
- 59 days
- Class
- Class II
- Product code
- MQP
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 8 generations to K003155 (2001). 21 ancestors in all, the oldest K841189 (1984). 39 later devices descend from it, 1 citing it directly.
- Root · 8 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 7 generations backK012254 VBROsteotech, Inc. · 2001
- 6 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 5 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 4 generations backK031780 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
- 3 generations backK040731 Stryker Spine Vertebral SpacerStryker Spine · 2004
- 2 generations backK042571 Stryker Spine Avs TL Peek SpacerStryker Spine · 2005
- 1 generation backK050624 Stryker Spine Avs PL Peek SpacerStryker Spine · 2005
- This deviceK053508 Synfix-LRSynthes Spine Co.Lp · 2006
- Descendant · cites it directly · 38 of its ownK110783 Venus Interbody Fixation System- Venus Plif/Tlif, Alif Peek CageL&K BIOMED Co., Ltd. · 2011
- Descendant · 2 generations on · 37 of its ownK120063 Venus Lumbar Intervertebral Body Fusion Cage SystemL&K BIOMED Co., Ltd. · 2012
- Descendant · 2 generations on · 36 of its ownK121096 Venus Lumbar Intervertebral Body Fusion Cage SystemL&K BIOMED Co., Ltd. · 2012
- Descendant · 2 generations on · 29 of its ownK151140 LnK Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd. · 2015
- Descendant · 3 generations on · 10 of its ownK181380 LnK Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd. · 2018
Showing 5 of 39 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 39 · See all- K110783Venus Interbody Fixation System- Venus Plif/Tlif, Alif Peek CageL&K BIOMED Co., Ltd. · 2011 · cites it directly38descendants
- K120063Venus Lumbar Intervertebral Body Fusion Cage SystemL&K BIOMED Co., Ltd. · 2012 · 2 generations on37descendants
- K121096Venus Lumbar Intervertebral Body Fusion Cage SystemL&K BIOMED Co., Ltd. · 2012 · 2 generations on36descendants
- K151140LnK Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd. · 2015 · 2 generations on29descendants
- K181380LnK Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd. · 2018 · 3 generations on10descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K003155 | Vertebral Body Replacement | Osteotech, Inc. | 2001 | — |
| −7 | K012254 | VBR | Osteotech, Inc. | 2001 | — |
| −6 | K021791 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −5 | K023570 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −4 | K031780 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2003 | — |
| −3 | K040731 | Stryker Spine Vertebral Spacer | Stryker Spine | 2004 | — |
| −2 | K042571 | Stryker Spine Avs TL Peek Spacer | Stryker Spine | 2005 | — |
| −1 | K050624 | Stryker Spine Avs PL Peek Spacer | Stryker Spine | 2005 | — |
| 0 (this device) | K053508 | Synfix-LR | Synthes Spine Co.Lp | 2006 | — |
| +1 | K110783 | Venus Interbody Fixation System- Venus Plif/Tlif, Alif Peek Cage | L&K BIOMED Co., Ltd. | 2011 | — |
| +2 | K120063 | Venus Lumbar Intervertebral Body Fusion Cage System | L&K BIOMED Co., Ltd. | 2012 | — |
| +2 | K121096 | Venus Lumbar Intervertebral Body Fusion Cage System | L&K BIOMED Co., Ltd. | 2012 | — |
| +2 | K151140 | LnK Lumbar Interbody Fusion Cage System | L&K BIOMED Co., Ltd. | 2015 | — |
| +3 | K181380 | LnK Lumbar Interbody Fusion Cage System | L&K BIOMED Co., Ltd. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 5 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2015 | 1 | 0 |
| 2017 | 5 | 0 |
| 2018 | 3 | 0 |
| 2019 | 4 | 0 |
| 2020 | 1 | 0 |
| 2021 | 4 | 0 |
| 2022 | 5 | 0 |
| 2023 | 8 | 0 |
| 2024 | 2 | 0 |
| 2025 | 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 MQP? 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…MQP Classification: 21 CER 888.3060 _____ ____ ____ ____ C lass H1 Predicate: K01 1037- Synthes Vertebral Spacer _____________K050624- Stryker Spine AVSTm PL PEEK Spacer Devic… | 2002 |
| * | K050624 | Stryker Spine Avs PL Peek SpacerSummary page 1…0 _____ ____ ____ ____ C lass H1 Predicate: K01 1037- Synthes Vertebral Spacer _____________K050624- Stryker Spine AVSTm PL PEEK Spacer Device Description: The Synthes SynfiXTM-LR… | 2005 |
What descends from it? (39)
See all 391 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K110783 | Venus Interbody Fixation System- Venus Plif/Tlif, Alif Peek Cage | 2011 | 38 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 23, 2010 | Not classified | Z-2583-2010 | Error in labeling | A potential for the implant holder tip to break off and lodge in the SynFix-LR implant, which pose a potential risk to the patient. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 5 years and passes through 4 companies; a new generation was cleared every 9 months on median.
- 1 of the 21 ancestors has a recall of any class.
- Of its descendants, K110783 (L&K BIOMED Co., Ltd., 2011) has gone furthest, with 38 descendants of its own.
- 10 other devices also cite its predicate K011037.
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.
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 SynFixTM-LR is a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body resected or excised during partial and total vertebrectomy procedure due to tumor or trauma (i.e., fracture). The SynFix TM-LR is intended to be used with Synthes supplemental internal fixation systems, e.g. ATLP, TSLP, VentroFix or USS. The interior of the spacer component of the SynFixTm-LR can be packed with bone (autograft or allograft).
SynFix TM-LR is designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053508 · printed Nov 5, 2026
Cite this page
510(k) Report. “K053508: Synfix-LR.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K053508
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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