510(k) · Cleared
Recalled · Class II · 2013Lanx Fusion System- SA
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lanx, Inc. · OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
Cleared on Mar 18, 2013 as substantially equivalent to K102738 (Lanx, LLC, 2011) after a 101-day review. Its family tree reaches back 8 generations to 1984. 324 later devices descend from it. It has been recalled 4 times.
- Decided
- Mar 18, 2013
- Review
- 101 days
- Class
- Class II
- Product code
- OVD
- Recalls
- 4
- Predicates
- 1
Its longest line of descent runs back 8 generations to K841189 (1984). 21 ancestors in all. 324 later devices descend from it, 7 citing it directly.
- Root · 8 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 7 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 6 generations backK020887 Ebi Ais Spine SystemEbi, L.P. · 2002
- 5 generations backK040482 Ebi Esl Spine Spacer SystemEbi, L.P. · 2004
- 4 generations backK042268 Ebi Cas Spine Spacer SystemEbi, L.P. · 2004
- 3 generations backK052384 Lanx VBR SystemLanx, LLC · 2005
- 2 generations backK083815 Lanx Fusion SystemLanx, Inc. · 2009
- 1 generation backK102738 Lanx Fusion SystemLanx, LLC · 2011 · Recalled
- This deviceK123767 Lanx Fusion System- SALanx, Inc. · 2013
- Descendant · cites it directly · 269 of its ownK131122 S128 Anterior Lumbar Interbody Fusion (Alif) SystemRenovis Surgical Technologies, LLC · 2013
- Descendant · 2 generations on · 265 of its ownK140106 S128 Anterior Lumbar Interbody Fusion (Alif) SystemRenovis Surgical Technologies, Inc. · 2014
- Descendant · 3 generations on · 254 of its ownK142095 Renovis S134 Anterior Lumbar Interbody Fusion (Alif) SystemRenovis Surgical Technologies, Inc. · 2014
- Descendant · 4 generations on · 237 of its ownK143126 Renovis S141 Lumbar Interbody Cage SystemRenovis Surgical Technologies · 2015
- Descendant · 5 generations on · 235 of its ownK151374 NuVasive MLX-Medial Lateral Expandable Lumbar Interbody System…Nu Vasive, Incorporated · 2015
Showing 5 of 324 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 324 · See all- K131122S128 Anterior Lumbar Interbody Fusion (Alif) SystemRenovis Surgical Technologies, LLC · 2013 · cites it directly269descendants
- K140106S128 Anterior Lumbar Interbody Fusion (Alif) SystemRenovis Surgical Technologies, Inc. · 2014 · 2 generations on265descendants
- K142095Renovis S134 Anterior Lumbar Interbody Fusion (Alif) SystemRenovis Surgical Technologies, Inc. · 2014 · 3 generations on254descendants
- K143126Renovis S141 Lumbar Interbody Cage SystemRenovis Surgical Technologies · 2015 · 4 generations on237descendants
- K151374NuVasive MLX-Medial Lateral Expandable Lumbar Interbody System, NuVasive AP Expandable…Nu Vasive, Incorporated · 2015 · 5 generations on235descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −7 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −6 | K020887 | Ebi Ais Spine System | Ebi, L.P. | 2002 | — |
| −5 | K040482 | Ebi Esl Spine Spacer System | Ebi, L.P. | 2004 | — |
| −4 | K042268 | Ebi Cas Spine Spacer System | Ebi, L.P. | 2004 | — |
| −3 | K052384 | Lanx VBR System | Lanx, LLC | 2005 | — |
| −2 | K083815 | Lanx Fusion System | Lanx, Inc. | 2009 | — |
| −1 | K102738 | Lanx Fusion System | Lanx, LLC | 2011 | 1 |
| 0 (this device) | K123767 | Lanx Fusion System- SA | Lanx, Inc. | 2013 | — |
| +1 | K131122 | S128 Anterior Lumbar Interbody Fusion (Alif) System | Renovis Surgical Technologies, LLC | 2013 | — |
| +2 | K140106 | S128 Anterior Lumbar Interbody Fusion (Alif) System | Renovis Surgical Technologies, Inc. | 2014 | — |
| +3 | K142095 | Renovis S134 Anterior Lumbar Interbody Fusion (Alif) System | Renovis Surgical Technologies, Inc. | 2014 | — |
| +4 | K143126 | Renovis S141 Lumbar Interbody Cage System | Renovis Surgical Technologies | 2015 | — |
| +5 | K151374 | NuVasive MLX-Medial Lateral Expandable Lumbar Interbody System, NuVasive AP… | Nu Vasive, Incorporated | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 2 | 0 |
| 2014 | 4 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 5 | 0 |
| 2018 | 16 | 0 |
| 2019 | 13 | 0 |
| 2020 | 25 | 0 |
| 2021 | 24 | 0 |
| 2022 | 36 | 0 |
| 2023 | 44 | 0 |
| 2024 | 60 | 0 |
| 2025 | 48 | 0 |
| 2026 | 43 | 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 OVD? 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? (1)
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 |
|---|---|---|---|
| * | K102738 | Lanx Fusion SystemSummary page 1…intervertebral body fixation orthosis (per 21 CFR § 888.3080 and/or §,888.3060) (OVD, MAX, MQP, ODP) Predicate Device Information K 102738 Lanx SA System Intended Use / Indications for Use When used as a cervical intervertebral body fusion device, the Lanx… | 2011 |
What descends from it? (324)
See all 3247 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 4, 2013 | Class II | Z-0400-2014 | Process control | Lanx, Inc. is recalling various lots of Timberline MPF Straight Split Tip Driver - Short ("Driver") because the width of the most distal end from the Driver handle (the tip of the hex portion of the Driver) is oversized. |
| Aug 22, 2013 | Class II | Z-0978-2015 | Component design/selection | The inner diameter of the Sleeve shaft is undersized, resulting in interference fit when inserting the Anchored Lateral Straight Retractable Awl or the Anchored Lateral Straight Retractable Drill into the Sleeve shaft. |
| Aug 22, 2013 | Class II | Z-0982-2015 | Component design/selection | The outer diameter of the Drill shaft is oversized; thereby, resulting in interference fit when inserting the Drill into the Fixed or Variable Sleeve Assembly. |
| Aug 22, 2013 | Class II | Z-0983-2015 | Device Design | The inner diameter of the Sleeve shaft is undersized, resulting in interference fit when inserting the Anchored Lateral Straight Retractable Awl or the Anchored Lateral Straight Retractable Drill into the Sleeve. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 29 years and passes through 5 companies; a new generation was cleared every 2.1 years on median.
- 3 of the 21 ancestors have a recall of any class.
- Of its descendants, K131122 (Renovis Surgical Technologies, LLC, 2013) has gone furthest, with 269 descendants of its own.
- 3 other devices also cite its predicate K102738.
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. 2013, 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?
When used as a cervical intervertebral body fusion device, the Lanx Intervertebral Body/VBR Fusion System ("Lanx Fusion System'") is intended for spinal fusion procedures to be used with autogenous bone raft in skeletally mature patients with degenerative disc disease ("DDD ") at one spinal level from the C2-C3 disc to the C7-TI disc. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic…
Read the full statement (464 words)
When used as a cervical intervertebral body fusion device, the Lanx Intervertebral Body/VBR Fusion System ("Lanx Fusion System'") is intended for spinal fusion procedures to be used with autogenous bone raft in skeletally mature patients with degenerative disc disease ("DDD ") at one spinal level from the C2-C3 disc to the C7-TI disc. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have had at least six weeks of non-operative treatment. The Lanx Cervical Intervertebral Body Fusion System is to be implanted via an anterior approach and is to be combined with supplemental fixation. Approved supplemental fixation systems include the JLanx Anterior Cervical Plate System.
When used as a lumbar intervertebral body fusion device, the Lanx Intervertebral Body/VBR Fusion System ("Lanx Fusion System') is intended for spinal fusion procedures to be used with autogenous bone raft in skeletally mature patients with degenerative disc disease ("DDD ') at one or two contiguous spinal levels from L2-SJ. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment. These DDD patients may have had a previous non-fusion spinal surgery at the involved, spinal level(s), and may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The Lanx Fusion System is to be combined with supplemental fixation (except as noted below). Approved supplemental fixation systems include the Lanx Spinal Fixation System. The Lanx SA standalone interbody implants, when implanted via an anterior approach and used with the integrated fixation screws, do not require use of supplemental fixation. The Lanx Lateral-SA implants are to be used with supplemental fixation.
When used as vertebral body replacement, the Lanx Intervertebral Body/VBR Fusion System ('Lanx Fusion System' ") is indicated for use to replace a vertebral body that has been resected or excised due to tumor or trauma/fracture. The device is intended for use as a vertebral body replacement in the thoracolumbar spine (from Ti to LS) The Lanx Vertebral Body Replacement System may also be used in the thoracolumbar spine (i.e. TI- LS) for partial replacement (h~e., partial vertebrectomy) of a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Lanx Vertebral Body Replacement System is also indicated for treating fractures of the thoracic and lumbar spine. The Lanx Vertebral Body Replacement System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column. For either indication the system must be used with supplemental internal fixation. Supplemental internal fixation is required to properly utilize this system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123767 · printed Nov 3, 2026
Cite this page
510(k) Report. “K123767: Lanx Fusion System- SA.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K123767
Report an extraction error
Are you the manufacturer?
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