510(k) · Cleared
ClearedBorn PT-LIF Cage HA
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spineworxx AG · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Feb 19, 2021 as substantially equivalent to K151785 (Innovasis, Inc., 2015) and 1 other predicate after a 183-day review. Its family tree reaches back 13 generations to 1984.
- Decided
- Feb 19, 2021
- Review
- 183 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 13 generations to K841189 (1984). 60 ancestors in all. No later device cites it as a predicate yet.
- 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 backK103169 AleuttianK2m, Inc. · 2011
- 1 generation backK130699 Aleutian Spinal SystemK2m, Inc. · 2013
- This deviceK202380 Born PT-LIF Cage HASpineworxx AG · 2021
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 backK103169 AleuttianK2m, Inc. · 2011
- 1 generation backK130699 Aleutian Spinal SystemK2m, Inc. · 2013
- This deviceK202380 Born PT-LIF Cage HASpineworxx AG · 2021
View 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 | K103169 | Aleuttian | K2m, Inc. | 2011 | — |
| −1 | K130699 | Aleutian Spinal System | K2m, Inc. | 2013 | — |
| 0 (this device) | K202380 | Born PT-LIF Cage HA | Spineworxx AG | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 4 | 0 |
| 2002 | 6 | 0 |
| 2003 | 9 | 0 |
| 2004 | 7 | 0 |
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 2007 | 5 | 0 |
| 2008 | 4 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2015 | 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 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 |
|---|---|---|---|
| * | K151785 | Px HA PEEK IBF SystemSummary page 4…t, Lumbar Device Classification: Class II Reviewing Panel: Orthopedic Product Code: MAX Predicate Device: K151785- Innovasis Px HA PEEK IBF System The predicate device has never been subject to recall. Additio… | 2015 |
| * | K130699 | Aleutian Spinal SystemSummary page 4…K151785- Innovasis Px HA PEEK IBF System The predicate device has never been subject to recall. Additional Predicate: K130699- Aleutian Spine System The additional predicate device has never been subject to… | 2013 |
What descends from it?
No later submission names this one as a predicate yet.
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 37 years and passes through 9 companies; a new generation was cleared every 1.6 years on median.
- 7 of the 60 ancestors have a recall of any class.
- 1 other device also cites its predicate K151785.
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. 2021, 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 Born PT-LIF Cage HA is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two levels of the spine from L2 to S1. These DDD patients may also have up to grade 1 spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six…
Read the full statement (115 words)
The Born PT-LIF Cage HA is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two levels of the spine from L2 to S1. These DDD patients may also have up to grade 1 spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain 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. These implants may be implanted in open surgery via a posterior or transforaminal approach. These devices are intended to be used with supplemental fixation which has been cleared for use in the lumbosacral spine.
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/K202380 · printed Nov 6, 2026
Cite this page
510(k) Report. “K202380: Born PT-LIF Cage HA.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K202380
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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