510(k) · Cleared
Recalled · 2008Synfix-LR Spacer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synthes Spine Co.Lp · OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
Cleared on Oct 12, 2007 as substantially equivalent to K062083 (Synthes Spine Co.Lp, 2007) and 1 other predicate after a 59-day review. Its family tree reaches back 2 generations to 2001. 1 of the 1,255 devices in its family, counting itself, has a Class I recall. 1,250 later devices descend from it. It has been recalled once.
- Decided
- Oct 12, 2007
- Review
- 59 days
- Class
- Class II
- Product code
- OVD
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 2 generations to K010530 (2001). 4 ancestors in all, the oldest P950002 (1996). 1,250 later devices descend from it, 28 citing it directly. 1 of the 1,255 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK010530 Geo StructureInterpore Cross Intl. · 2001
- 1 generation backK062083 Synfix -LRSynthes Spine Co.Lp · 2007
- This deviceK072253 Synfix-LR SpacerSynthes Spine Co.Lp · 2007
- Descendant · cites it directly · 1,102 of its ownK073470 Avs PL Peek Spacers, Models 48351XXX and 48353XXXStryker Spine · 2008
- Descendant · 2 generations on · 1,091 of its ownK080758 Avs PL Peek Spacers, Models 48351 and 48353Stryker Corp. · 2008
- Descendant · cites it directly · 932 of its ownK080083 Intrepid Spinal SystemMedtronic Sofamor Danek · 2008 · Recalled
- Descendant · 2 generations on · 907 of its ownK073109 Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd. · 2008
- Descendant · cites it directly · 854 of its ownK081395 Solitaire Peek-Optima Anterior Spinal SystemBiomet Spine · 2008
Showing 5 of 1,250 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub6 generations on · 2021
Most influential descendants
Showing 5 of 1,250 · See all- K073470Avs PL Peek Spacers, Models 48351XXX and 48353XXXStryker Spine · 2008 · cites it directly1,102descendants
- K080758Avs PL Peek Spacers, Models 48351 and 48353Stryker Corp. · 2008 · 2 generations on1,091descendants
- K080083Intrepid Spinal SystemMedtronic Sofamor Danek · 2008 · cites it directly932descendants
- K073109Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd. · 2008 · 2 generations on907descendants
- K081395Solitaire Peek-Optima Anterior Spinal SystemBiomet Spine · 2008 · cites it directly854descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K010530 | Geo Structure | Interpore Cross Intl. | 2001 | — |
| −1 | K062083 | Synfix -LR | Synthes Spine Co.Lp | 2007 | — |
| 0 (this device) | K072253 | Synfix-LR Spacer | Synthes Spine Co.Lp | 2007 | — |
| +1 | K073470 | Avs PL Peek Spacers, Models 48351XXX and 48353XXX | Stryker Spine | 2008 | — |
| +2 | K080758 | Avs PL Peek Spacers, Models 48351 and 48353 | Stryker Corp. | 2008 | — |
| +1 | K080083 | Intrepid Spinal System | Medtronic Sofamor Danek | 2008 | 8 |
| +2 | K073109 | Stalif TT Intervertebral Body Fusion System | Surgicraft, Ltd. | 2008 | — |
| +1 | K081395 | Solitaire Peek-Optima Anterior Spinal System | Biomet Spine | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 OVD device
- #1 K222009 aprevo® anterior lumbar interbody fusion…score 26.0 · 23 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 |
|---|---|---|---|
| * | K062083 | Synfix -LRSummary page 1…body fusion device Class II (special controls) Orthopaedic and Rehabilitation Devices Panel (87) Product Code MAX (orthosis, spinal intervertebral fusion) Predicates: K062083 Synthes SynFix™-LR P950002 BAK Intervertebral Body Fusion Device Device Description: The Synthes SynFix™.-LR is a combination r… | 2007 |
| * | P950002 | Bak Interbody Fusion SystemSummary page 1…(special controls) Orthopaedic and Rehabilitation Devices Panel (87) Product Code MAX (orthosis, spinal intervertebral fusion) Predicates: K062083 Synthes SynFix™-LR P950002 BAK Intervertebral Body Fusion Device Device Description: The Synthes SynFix™.-LR is a combination radiolucent and radiopaque i… | 1996 |
What descends from it? (1,250)
See all 1,25028 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K073470 | Avs PL Peek Spacers, Models 48351XXX and 48353XXX | 2008 | 1,102 |
| K080083 | Intrepid Spinal System | 2008 | 932 |
| K081395 | Solitaire Peek-Optima Anterior Spinal System | 2008 | 854 |
| K073177 | Pioneer Intervertebral Fusion Device System | 2008 | 775 |
| K100043 | Coroent XLR Standalone System | 2010 | 744 |
| K072981 | Synthes Zero-P | 2008 | 546 |
| K081636 | Peek-Optima Alif Spacer | 2008 | 542 |
| K091301 | Life Spine Stand-Alone Spacer System | 2009 | 473 |
| K100802 | Aesculap Implant Systems Sibd Spinal System | 2010 | 461 |
| K092211 | Chesapeake Spinal System | 2010 | 450 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 20, 2008 | Not classified | Z-0931-2009 | Device Design | screwdriver tip may break off and lodge in the screw head |
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 · 6 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 6 years and passes through 2 companies; a new generation was cleared every 5.7 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K073470 (Stryker Spine, 2008) has gone furthest, with 1,102 descendants of its own.
- 5 other devices also cite its predicate K062083.
How does its category compare?
All OVD devicesOVD Intervertebral Fusion Device With Integrated Fixation, Lumbar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · OVD
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OVD
100in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OVD
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OVD
50in 2025
MAUDE reports naming product code OVD, 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 | 2 | — | 0 | 0 |
| 2008 | 8 | 84 | 0 | 0 |
| 2009 | 3 | 152 | 0 | 2 |
| 2010 | 8 | 117 | 0 | 2 |
| 2011 | 9 | 167 | 0 | 6 |
| 2012 | 10 | 78 | 0 | 16 |
| 2013 | 11 | 137 | 4 | 17 |
| 2014 | 14 | 139 | 0 | 35 |
| 2015 | 12 | 166 | 0 | 43 |
| 2016 | 13 | 127 | 1 | 55 |
| 2017 | 12 | 127 | 0 | 72 |
| 2018 | 14 | 126 | 0 | 112 |
| 2019 | 12 | 91 | 0 | 171 |
| 2020 | 14 | 91 | 0 | 203 |
| 2021 | 7 | 108 | 1 | 221 |
| 2022 | 14 | 133 | 1 | 74 |
| 2023 | 12 | 92 | 0 | 67 |
| 2024 | 12 | 110 | 0 | 92 |
| 2025 | 10 | 100 | 1 | 50 |
| 2026 | 8 | 93 | 1 | — |
What is it indicated for?
The SynFix-LR device is a stand-alone anterior interbody fusion device indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). The interior of the spacer component of the SynFix~LR can be packed with autograft.
DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K072253 · printed Nov 4, 2026
Cite this page
510(k) Report. “K072253: Synfix-LR Spacer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072253
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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