510(k) · Cleared
Cleared3d Cage Cervical
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fims Co., Ltd. · ODP Intervertebral Fusion Device With Bone Graft, Cervical
Cleared on Jul 23, 2026 as substantially equivalent to K170503 (Eit Emerging Implant Technologies GmbH, 2017) after a 304-day review. Its family tree reaches back 16 generations to 1984. 1 of the 119 devices in its family, counting itself, has a Class I recall.
- Decided
- Jul 23, 2026
- Review
- 304 days
- Class
- Class II
- Product code
- ODP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 16 generations to K841189 (1984). 118 ancestors in all. No later device cites it as a predicate yet. 1 of the 119 devices in this family, counting this one, has a Class I recall.
- Root · 16 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 12 generations between
- 3 generations backK133614 Aleutian Ibf SystemK2m, Inc. · 2014
- 2 generations backK143258 PLIF STS, TLIF STS, OLIF STS (Spinal Truss System)4Web, Inc. · 2015
- 1 generation backK170503 EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF…Eit Emerging Implant Technologies GmbH · 2017 · Recalled
- This deviceK253041 3d Cage CervicalFims Co., Ltd. · 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 backK051454 Aleutian Spacer SystemK2m, LLC · 2005
- 8 generations backK063399 Aleutian Spacer SystemK2m, Inc. · 2007
- 7 generations backK082698 Aleutian Ibf SystemK2m, Inc. · 2009
- 6 generations backK101302 Aleutian Ibf SystemK2m, Inc. · 2010
- 5 generations backK103169 AleuttianK2m, Inc. · 2011
- 4 generations backK130699 Aleutian Spinal SystemK2m, Inc. · 2013
- 3 generations backK133614 Aleutian Ibf SystemK2m, Inc. · 2014
- 2 generations backK143258 PLIF STS, TLIF STS, OLIF STS (Spinal Truss System)4Web, Inc. · 2015
- 1 generation backK170503 EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF…Eit Emerging Implant Technologies GmbH · 2017 · Recalled
- This deviceK253041 3d Cage CervicalFims Co., Ltd. · 2026
Class I recalls in this family
- K073202 Ardis Spacer3 generations back · 2008
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 | K051454 | Aleutian Spacer System | K2m, LLC | 2005 | — |
| −8 | K063399 | Aleutian Spacer System | K2m, Inc. | 2007 | — |
| −7 | K082698 | Aleutian Ibf System | K2m, Inc. | 2009 | — |
| −6 | K101302 | Aleutian Ibf System | K2m, Inc. | 2010 | — |
| −5 | K103169 | Aleuttian | K2m, Inc. | 2011 | — |
| −4 | K130699 | Aleutian Spinal System | K2m, Inc. | 2013 | — |
| −3 | K133614 | Aleutian Ibf System | K2m, Inc. | 2014 | — |
| −2 | K143258 | PLIF STS, TLIF STS, OLIF STS (Spinal Truss System) | 4Web, Inc. | 2015 | — |
| −1 | K170503 | EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT… | Eit Emerging Implant Technologies GmbH | 2017 | 2 |
| 0 (this device) | K253041 | 3d Cage Cervical | Fims Co., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 10 | 0 |
| 2002 | 8 | 0 |
| 2003 | 11 | 0 |
| 2004 | 13 | 0 |
| 2005 | 10 | 0 |
| 2006 | 2 | 0 |
| 2007 | 10 | 0 |
| 2008 | 13 | 1 |
| 2009 | 8 | 0 |
| 2010 | 2 | 0 |
| 2011 | 8 | 0 |
| 2012 | 1 | 0 |
| 2013 | 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.
1 device in this family has a Class I recall. 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 ODP device
- #1 K222276 CONDUIT Cages; FIBERGRAFT BG Puttyscore 53.4 · 25 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 |
|---|---|---|---|
| * | K170503 | EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT Cellular…Summary page 5…r 888.3080 Product Code(s) ODP I Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K170503 EIT Cellular Titanium ® ODP Cervical Cage Device Description Summary 21 CFR 807.92(a)(4) The 3d Cage Cervical is a cervical inte… | 2017 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K073202Ardis SpacerAbbott Spine, Inc. · 2008 · 3 generations back · ◆ in the 2008 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 42 years and passes through 11 companies; a new generation was cleared every 1.6 years on median.
- 17 of the 118 ancestors have a recall of any class; 1 has a Class I recall.
- 15 other devices also cite its predicate K170503.
How does its category compare?
All ODP devicesODP Intervertebral Fusion Device With Bone Graft, Cervical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · ODP
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ODP
87in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ODP
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ODP
57in 2025
MAUDE reports naming product code ODP, 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 | 0 | — | 0 | 0 |
| 2008 | 8 | 89 | 0 | 2 |
| 2009 | 12 | 127 | 1 | 21 |
| 2010 | 9 | 151 | 0 | 54 |
| 2011 | 25 | 113 | 1 | 38 |
| 2012 | 17 | 93 | 0 | 92 |
| 2013 | 18 | 187 | 1 | 78 |
| 2014 | 26 | 118 | 0 | 43 |
| 2015 | 24 | 180 | 0 | 51 |
| 2016 | 17 | 112 | 0 | 37 |
| 2017 | 33 | 104 | 0 | 39 |
| 2018 | 25 | 133 | 0 | 51 |
| 2019 | 22 | 92 | 0 | 141 |
| 2020 | 14 | 89 | 1 | 86 |
| 2021 | 18 | 121 | 0 | 161 |
| 2022 | 12 | 92 | 0 | 50 |
| 2023 | 34 | 165 | 0 | 36 |
| 2024 | 10 | 76 | 0 | 55 |
| 2025 | 11 | 87 | 2 | 57 |
| 2026 | 19 | 117 | 0 | — |
What is it indicated for?
The 3d Cage Cervical are intervertebral body fusion devices indicated for use with autograft when used as an adjunct to
fusion in patients with cervical disc disease (DDD) at one level from the C2-C3 disc to the C7-T1 disc. DDD is defined as
neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients
should be skeletally mature and have had six weeks of non operative treatment. The 3d Cage Cervical are also to be used
with supplemental fixation systems that have been cleared for use in the cervical 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/K253041 · printed Nov 4, 2026
Cite this page
510(k) Report. “K253041: 3d Cage Cervical.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K253041
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026