510(k) · Cleared
ClearedSahara Stabilization System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
K2m, Inc. · OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
Cleared on Dec 21, 2015 as substantially equivalent to K092211 (K2m, Inc., 2010) and 5 other predicates after a 202-day review. Its family tree reaches back 16 generations to 1984. 5 later devices descend from it.
- Decided
- Dec 21, 2015
- Review
- 202 days
- Class
- Class II
- Product code
- OVD
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 16 generations to K841189 (1984). 150 ancestors in all, the oldest K792352 (1979). 5 later devices descend from it, 1 citing it directly.
- Root · 16 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 12 generations between
- 3 generations backK111439 Chesapeake (Cervical Components)K2m, Inc. · 2011 · Recalled
- 2 generations backK133494 Chesapeake Spinal SystemK2m, Inc. · 2014
- 1 generation backK142487 Chesapeake Stabilization SystemK2m, Inc. · 2015 · Recalled
- This deviceK151481 Sahara Stabilization SystemK2m, Inc. · 2015
- Descendant · cites it directly · 4 of its ownK201585 Monterey AL Interbody SystemStryker Corporation · 2020 · Recalled
- Descendant · 2 generations on · 1 of its ownK250072 CONDUIT™ SYNFIX™ Evolution Secured Spacer SystemAvalign Technologies, Inc. · 2025
- Descendant · 2 generations on · 1 of its ownK221490 Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL…Stryker Spine · 2023
- Descendant · 3 generations on · 0 of its ownK262061 Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium®…Stryker Spine · 2026
- Descendant · 3 generations on · 0 of its ownK252982 CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc. · 2026
Show all 16 generations
- Root · 16 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 15 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 14 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 13 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 12 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 11 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 10 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 9 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 8 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 7 generations backK080083 Intrepid Spinal SystemMedtronic Sofamor Danek · 2008 · Recalled
- 6 generations backK073109 Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd. · 2008
- 5 generations backK083475 Lucent MagnumSpinal Elements, Inc. · 2009
- 4 generations backK092211 Chesapeake Spinal SystemK2m, Inc. · 2010
- 3 generations backK111439 Chesapeake (Cervical Components)K2m, Inc. · 2011 · Recalled
- 2 generations backK133494 Chesapeake Spinal SystemK2m, Inc. · 2014
- 1 generation backK142487 Chesapeake Stabilization SystemK2m, Inc. · 2015 · Recalled
- This deviceK151481 Sahara Stabilization SystemK2m, Inc. · 2015
Most influential descendants
Showing 5 of 5 · See all- K201585Monterey AL Interbody SystemStryker Corporation · 2020 · cites it directly4descendants
- K250072CONDUIT™ SYNFIX™ Evolution Secured Spacer SystemAvalign Technologies, Inc. · 2025 · 2 generations on1descendant
- K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine · 2023 · 2 generations on1descendant
- K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…Stryker Spine · 2026 · 3 generations on0descendants
- K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc. · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −15 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −14 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −13 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −12 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −11 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −10 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −9 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −8 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −7 | K080083 | Intrepid Spinal System | Medtronic Sofamor Danek | 2008 | 8 |
| −6 | K073109 | Stalif TT Intervertebral Body Fusion System | Surgicraft, Ltd. | 2008 | — |
| −5 | K083475 | Lucent Magnum | Spinal Elements, Inc. | 2009 | — |
| −4 | K092211 | Chesapeake Spinal System | K2m, Inc. | 2010 | — |
| −3 | K111439 | Chesapeake (Cervical Components) | K2m, Inc. | 2011 | 1 |
| −2 | K133494 | Chesapeake Spinal System | K2m, Inc. | 2014 | — |
| −1 | K142487 | Chesapeake Stabilization System | K2m, Inc. | 2015 | 1 |
| 0 (this device) | K151481 | Sahara Stabilization System | K2m, Inc. | 2015 | — |
| +1 | K201585 | Monterey AL Interbody System | Stryker Corporation | 2020 | 4 |
| +2 | K250072 | CONDUIT™ SYNFIX™ Evolution Secured Spacer System | Avalign Technologies, Inc. | 2025 | — |
| +2 | K221490 | Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved… | Stryker Spine | 2023 | — |
| +3 | K262061 | Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved… | Stryker Spine | 2026 | — |
| +3 | K252982 | CONDUIT™ ZERO-P™ VA Secured Spacer System | Avalign Technologies, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1996 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 10 | 0 |
| 2002 | 8 | 0 |
| 2003 | 13 | 0 |
| 2004 | 21 | 0 |
| 2005 | 11 | 0 |
| 2006 | 7 | 0 |
| 2007 | 10 | 0 |
| 2008 | 20 | 0 |
| 2009 | 9 | 0 |
| 2010 | 4 | 0 |
| 2011 | 4 | 0 |
| 2012 | 5 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 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? (6)
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 |
|---|---|---|---|
| * | K092211 | Chesapeake Spinal SystemSummary page 4…ification Name(s): Intervertebral Body Fusion Device with Integrated Fusion (21 CFR 888.3080, Product Code OVD) Predicate Device(s) Primary Predicate: K2M Chesapeake (K092211) Additional Predicates: K2M Chesapeake (K120031, 142487) K2M Santorini (K111294) Globus Rise (K113447) Wenzel Spine Vari-Lift-L (… | 2010 |
| * | K120031 | Chesapeake Spinal SystemSummary page 4…vice with Integrated Fusion (21 CFR 888.3080, Product Code OVD) Predicate Device(s) Primary Predicate: K2M Chesapeake (K092211) Additional Predicates: K2M Chesapeake (K120031, 142487) K2M Santorini (K111294) Globus Rise (K113447) Wenzel Spine Vari-Lift-L (K100820) Device Description The subject of thi… | 2012 |
| * | K142487 | Chesapeake Stabilization SystemSummary page 4…Integrated Fusion (21 CFR 888.3080, Product Code OVD) Predicate Device(s) Primary Predicate: K2M Chesapeake (K092211) Additional Predicates: K2M Chesapeake (K120031, 142487) K2M Santorini (K111294) Globus Rise (K113447) Wenzel Spine Vari-Lift-L (K100820) Device Description The subject of this 510(k)… | 2015 |
| * | K111294 | Santorini Spinal SystemSummary page 4…CFR 888.3080, Product Code OVD) Predicate Device(s) Primary Predicate: K2M Chesapeake (K092211) Additional Predicates: K2M Chesapeake (K120031, 142487) K2M Santorini (K111294) Globus Rise (K113447) Wenzel Spine Vari-Lift-L (K100820) Device Description The subject of this 510(k) submission is the Sahar… | 2012 |
| * | K113447 | Rise SpacerSummary page 4…Code OVD) Predicate Device(s) Primary Predicate: K2M Chesapeake (K092211) Additional Predicates: K2M Chesapeake (K120031, 142487) K2M Santorini (K111294) Globus Rise (K113447) Wenzel Spine Vari-Lift-L (K100820) Device Description The subject of this 510(k) submission is the Sahara Stabilization System… | 2012 |
| * | K100820 | Wenzel Spine Varilift Interbody Fusion SystemSummary page 4…imary Predicate: K2M Chesapeake (K092211) Additional Predicates: K2M Chesapeake (K120031, 142487) K2M Santorini (K111294) Globus Rise (K113447) Wenzel Spine Vari-Lift-L (K100820) Device Description The subject of this 510(k) submission is the Sahara Stabilization System. The implants function as an expan… | 2010 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K201585 | Monterey AL Interbody System | 2020 | 4 |
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 31 years and passes through 11 companies; a new generation was cleared every 1.0 years on median.
- 17 of the 150 ancestors have a recall of any class.
- Of its descendants, K201585 (Stryker Corporation, 2020) has gone furthest, with 4 descendants of its own.
- 4 other devices also cite its predicate K092211.
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. 2015, 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 SAHARA Stabilization System implants are indicated for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients. Lumbar implants are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis or retrolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc…
Read the full statement (157 words)
The SAHARA Stabilization System implants are indicated for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients. Lumbar implants are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis or retrolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is intended to be used in patients who have had six months of non-operative treatment.
The hyperlordotic lumbar implants (at angles > 15°) must be used with supplemental fixation (i.e., posterior pedicle screw and rod system) cleared for use in the lumbar spine, in addition to the bone screws provided. Otherwise, the Sahara Stabilization System implants may be used as a stand-alone device, which is intended to be used with the bone screws provided.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K151481 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151481: Sahara Stabilization System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151481
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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