510(k) · Cleared
ClearedPrimalif TM Llif Unitary Peek Lateral Lumbar Interbody Fusion System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Osteomed LP · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Nov 29, 2012 as substantially equivalent to K103666 (Lanx, Inc., 2011) and 2 other predicates after a 48-day review. Its family tree reaches back 8 generations to 1984. 16 later devices descend from it.
- Decided
- Nov 29, 2012
- Review
- 48 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 8 generations to K841189 (1984). 31 ancestors in all. 16 later devices descend from it, 2 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 backK103666 Lanx LateralLanx, Inc. · 2011
- This deviceK123207 Primalif TM Llif Unitary Peek Lateral Lumbar Interbody Fusion SystemOsteomed LP · 2012
- Descendant · cites it directly · 8 of its ownK160976 Altus Spine Interbody Fusion SystemAltus Partners, LLC · 2017
- Descendant · 2 generations on · 6 of its ownK170512 Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC · 2017
- Descendant · cites it directly · 6 of its ownK131540 Interfuse L Intervertebral Body Fusion DeviceVertebral Technologies, Inc. · 2013
- Descendant · 2 generations on · 5 of its ownK160074 Rampart D Lumbar Interbody Fusion DeviceSpineology, Inc. · 2016
- Descendant · 3 generations on · 4 of its ownK171660 Duo Lumbar Interbody Fusion DeviceSpineology, Inc. · 2017
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K160976Altus Spine Interbody Fusion SystemAltus Partners, LLC · 2017 · cites it directly8descendants
- K170512Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC · 2017 · 2 generations on6descendants
- K131540Interfuse L Intervertebral Body Fusion DeviceVertebral Technologies, Inc. · 2013 · cites it directly6descendants
- K160074Rampart D Lumbar Interbody Fusion DeviceSpineology, Inc. · 2016 · 2 generations on5descendants
- K171660Duo Lumbar Interbody Fusion DeviceSpineology, Inc. · 2017 · 3 generations on4descendants
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 | K103666 | Lanx Lateral | Lanx, Inc. | 2011 | — |
| 0 (this device) | K123207 | Primalif TM Llif Unitary Peek Lateral Lumbar Interbody Fusion System | Osteomed LP | 2012 | — |
| +1 | K160976 | Altus Spine Interbody Fusion System | Altus Partners, LLC | 2017 | — |
| +2 | K170512 | Altus Spine Titanium Interbody Fusion System | Altus Partners, LLC | 2017 | — |
| +1 | K131540 | Interfuse L Intervertebral Body Fusion Device | Vertebral Technologies, Inc. | 2013 | — |
| +2 | K160074 | Rampart D Lumbar Interbody Fusion Device | Spineology, Inc. | 2016 | — |
| +3 | K171660 | Duo Lumbar Interbody Fusion Device | Spineology, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 3 | 0 |
| 2003 | 4 | 0 |
| 2004 | 4 | 0 |
| 2005 | 2 | 0 |
| 2007 | 3 | 0 |
| 2008 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 6 | 0 |
| 2018 | 3 | 0 |
| 2019 | 3 | 0 |
| 2021 | 1 | 0 |
| 2022 | 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 MAX? 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 MAX device
- #1 K203714 NuVasive Thoracolumbar Interbody Systems…score 102.5 · 24 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K103666 | Lanx LateralSummary page 3…larities in intended use, anatomic location, mechanical properties and method of stabilization to the predicate devices including the Lanx Lateral (K103666), the DePuy Lumbar I/F Cage (P960025), and the Synthes Oracle Spacer (K07279 1), based on their promotional… | 2011 |
| * | P960025 | Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle ScrewsSummary page 1…ion Name: Orthosis, spinal intervertebral fusion (21 CFR 888.3080 Product Code: MAX) Device Class: 11 DePuv Lumbar I/F Cage with VSP Spine System (P960025) Classification Name: Intervertebral Fusion Device with Bone Graft, lumbar (21 CFR 888.3080 Product Code: MAX)… | 1999 |
| * | K072791 | Oracle Spacer, Opal SpacerSummary page 1…ssification Name: Intervertebral Fusion Device with Bone Graft, lumbar (21 CFR 888.3080 Product Code: MAX) Device Class: 11 Synthes Oracle Spacer (K072791) Classification Name: Spinal Intervertebral Body Fusion (21 CFR 888.3080 Product Code: MAX) Device Class:… | 2007 |
What descends from it? (16)
See all 162 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 28 years and passes through 6 companies; a new generation was cleared every 1.9 years on median.
- 4 of the 31 ancestors have a recall of any class.
- Of its descendants, K160976 (Altus Partners, LLC, 2017) has gone furthest, with 8 descendants of its own.
- 4 other devices also cite its predicate K103666.
How does its category compare?
All MAX devicesMAX Intervertebral Fusion Device With Bone Graft, Lumbar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · MAX
29in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MAX
85in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MAX
5in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · MAX
811in 2025
MAUDE reports naming product code MAX, 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 | 7 | 86 | 0 | 12 |
| 2008 | 35 | 88 | 2 | 19 |
| 2009 | 31 | 102 | 9 | 90 |
| 2010 | 29 | 137 | 0 | 154 |
| 2011 | 49 | 98 | 3 | 201 |
| 2012 | 48 | 69 | 11 (1) | 327 |
| 2013 | 58 | 102 | 0 | 380 |
| 2014 | 58 | 115 | 3 | 366 |
| 2015 | 53 | 113 | 1 | 524 |
| 2016 | 64 | 124 | 6 | 647 |
| 2017 | 76 | 116 | 1 | 596 |
| 2018 | 64 | 114 | 4 | 616 |
| 2019 | 60 | 131 | 1 | 699 |
| 2020 | 56 | 106 | 0 | 640 |
| 2021 | 53 | 109 | 0 | 622 |
| 2022 | 41 | 95 | 1 | 618 |
| 2023 | 30 | 87 | 0 | 576 |
| 2024 | 38 | 91 | 1 | 729 |
| 2025 | 29 | 85 | 5 | 811 |
| 2026 | 18 | 95 | 0 | — |
What is it indicated for?
The PrimaLIFrm LLIF Unitary PEEK Lateral Lumbar Interbody Fusion System (PrimaLIF Tm LLIF) is indicated for intervertebral body fusion of the lumbar spine to be used with autogenous bone graft, from L2 to SI, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) and these patients may have up to…
Read the full statement (141 words)
The PrimaLIFrm LLIF Unitary PEEK Lateral Lumbar Interbody Fusion System (PrimaLIF Tm LLIF) is indicated for intervertebral body fusion of the lumbar spine to be used with autogenous bone graft, from L2 to SI, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) and these patients may have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc, confirmed by history and radiographic studies. The device is intended for use with supplemental fixation systems such as PrimaLOKTM SP and PrimaLOKTM FE which have been cleared for use in the lumbar spine.
The PrimaLIPrm LLIF implants are intended for single use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123207 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123207: Primalif TM Llif Unitary Peek Lateral Lumbar Interbody Fusion System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123207
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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