510(k) · Cleared
ClearedSterispine LC Cage
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Safe Orthopaedics · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Sep 20, 2012 as substantially equivalent to P960025 (Depuy Spine, Inc., 1999) and 1 other predicate after a 72-day review. Its family tree reaches back 13 generations to 1984. 2 later devices descend from it.
- Decided
- Sep 20, 2012
- Review
- 72 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 13 generations to K841189 (1984). 63 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 13 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 9 generations between
- 3 generations backK101302 Aleutian Ibf SystemK2m, Inc. · 2010
- 2 generations backK110843 Aleutian Spacer SystemK2m, Inc. · 2011
- 1 generation backK112664 Zavation Ibf SystemsZavation, LLC · 2011
- This deviceK122021 Sterispine LC CageSafe Orthopaedics · 2012
- Descendant · cites it directly · 1 of its ownK133893 Sterispine LC CageSafe Orthopaedics · 2014
- Descendant · cites it directly · 0 of its ownK151756 Sterispine LC CageSafe Orthopaedics · 2015
Show all 13 generations
- Root · 13 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 12 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 11 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 10 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 9 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 8 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 7 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 6 generations backK051454 Aleutian Spacer SystemK2m, LLC · 2005
- 5 generations backK063399 Aleutian Spacer SystemK2m, Inc. · 2007
- 4 generations backK082698 Aleutian Ibf SystemK2m, Inc. · 2009
- 3 generations backK101302 Aleutian Ibf SystemK2m, Inc. · 2010
- 2 generations backK110843 Aleutian Spacer SystemK2m, Inc. · 2011
- 1 generation backK112664 Zavation Ibf SystemsZavation, LLC · 2011
- This deviceK122021 Sterispine LC CageSafe Orthopaedics · 2012
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −12 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −11 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −10 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −9 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −8 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −7 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −6 | K051454 | Aleutian Spacer System | K2m, LLC | 2005 | — |
| −5 | K063399 | Aleutian Spacer System | K2m, Inc. | 2007 | — |
| −4 | K082698 | Aleutian Ibf System | K2m, Inc. | 2009 | — |
| −3 | K101302 | Aleutian Ibf System | K2m, Inc. | 2010 | — |
| −2 | K110843 | Aleutian Spacer System | K2m, Inc. | 2011 | — |
| −1 | K112664 | Zavation Ibf Systems | Zavation, LLC | 2011 | — |
| 0 (this device) | K122021 | Sterispine LC Cage | Safe Orthopaedics | 2012 | — |
| +1 | K133893 | Sterispine LC Cage | Safe Orthopaedics | 2014 | — |
| +1 | K151756 | Sterispine LC Cage | Safe Orthopaedics | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 9 | 0 |
| 2002 | 7 | 0 |
| 2003 | 7 | 0 |
| 2004 | 9 | 0 |
| 2005 | 4 | 0 |
| 2007 | 1 | 0 |
| 2008 | 6 | 0 |
| 2009 | 3 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 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? (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 |
|---|---|---|---|
| * | P960025 | Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle ScrewsSummary page 1…ertebral body fusion device Class II Product Code MAX CFR section 888.3080 Device panel Orthopei Legally marketed Lumbar I/F cage (P960025) manufactured by Depuy Acromed predicate devices Zavation 1SF System (K112664) manufactured by Zavation LL… | 1999 |
| * | K112664 | Zavation Ibf SystemsSummary page 1…ection 888.3080 Device panel Orthopei Legally marketed Lumbar I/F cage (P960025) manufactured by Depuy Acromed predicate devices Zavation 1SF System (K112664) manufactured by Zavation LL SteriSpine TNLC range of products consists of lumbar Interbody… | 2011 |
What descends from it? (2)
2 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 10 companies; a new generation was cleared every 1.0 years on median.
- 8 of the 63 ancestors have a recall of any class.
- Of its descendants, K133893 (Safe Orthopaedics, 2014) has gone furthest, with 1 descendant of its own.
- 98 other devices also cite its predicate P960025.
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 STERISPINE LC device is indicated for intervertebral body fusion procedures at one or two contiguous levels from L2 to S1 in skeletally mature patients with degenerative disc disease (DDD) with up to Grade I spondylolisthesis at the involved level(s). DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.
This device is to be used with autogenous bone graft to facilitate fusion and is intended for use with STERISPINE PS, a supplemental fixation system cleared by the FDA for use in the lumbar spine.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122021 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122021: Sterispine LC Cage.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122021
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