510(k) · Cleared
ClearedCAPRI
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
K2m, Inc. · MQP Spinal Vertebral Body Replacement Device
Cleared on Nov 6, 2014 as substantially equivalent to K111294 (K2m, Inc., 2012) and 3 other predicates after a 104-day review. Its family tree reaches back 9 generations to 1984. 12 later devices descend from it.
- Decided
- Nov 6, 2014
- Review
- 104 days
- Class
- Class II
- Product code
- MQP
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 9 generations to K841189 (1984). 34 ancestors in all. 12 later devices descend from it, 2 citing it directly.
- Root · 9 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 5 generations between
- 3 generations backK050058 Theken Reveal VBR SystemTheken Surgical,Llc · 2005
- 2 generations backK070381 Theken VU Mesh VBR SystemTheken Spine, LLC · 2007
- 1 generation backK111294 Santorini Spinal SystemK2m, Inc. · 2012
- This deviceK142016 CAPRIK2m, Inc. · 2014
- Descendant · cites it directly · 11 of its ownK170055 CAPRI Corpectomy Cage SystemK2m · 2017
- Descendant · cites it directly · 10 of its ownK171704 CAPRI Corpectomy Cage SystemK2m · 2017
- Descendant · 2 generations on · 9 of its ownK180665 SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage SystemK2m, LLC · 2018
- Descendant · 3 generations on · 2 of its ownK211320 CAPRI Corpectomy Cage SystemK2m, Inc. · 2022
- Descendant · 3 generations on · 1 of its ownK221490 Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL…Stryker Spine · 2023
Show all 9 generations
- Root · 9 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 8 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 7 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 6 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 5 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 4 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 3 generations backK050058 Theken Reveal VBR SystemTheken Surgical,Llc · 2005
- 2 generations backK070381 Theken VU Mesh VBR SystemTheken Spine, LLC · 2007
- 1 generation backK111294 Santorini Spinal SystemK2m, Inc. · 2012
- This deviceK142016 CAPRIK2m, Inc. · 2014
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K170055CAPRI Corpectomy Cage SystemK2m · 2017 · cites it directly11descendants
- K171704CAPRI Corpectomy Cage SystemK2m · 2017 · cites it directly10descendants
- K180665SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage SystemK2m, LLC · 2018 · 2 generations on9descendants
- K211320CAPRI Corpectomy Cage SystemK2m, Inc. · 2022 · 3 generations on2descendants
- K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine · 2023 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −8 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −7 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −6 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −5 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −4 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −3 | K050058 | Theken Reveal VBR System | Theken Surgical,Llc | 2005 | — |
| −2 | K070381 | Theken VU Mesh VBR System | Theken Spine, LLC | 2007 | — |
| −1 | K111294 | Santorini Spinal System | K2m, Inc. | 2012 | — |
| 0 (this device) | K142016 | CAPRI | K2m, Inc. | 2014 | — |
| +1 | K170055 | CAPRI Corpectomy Cage System | K2m | 2017 | — |
| +1 | K171704 | CAPRI Corpectomy Cage System | K2m | 2017 | — |
| +2 | K180665 | SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage System | K2m, LLC | 2018 | — |
| +3 | K211320 | CAPRI Corpectomy Cage System | K2m, Inc. | 2022 | — |
| +3 | K221490 | Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved… | Stryker Spine | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 8 | 0 |
| 2002 | 4 | 0 |
| 2003 | 4 | 0 |
| 2004 | 4 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2020 | 3 | 0 |
| 2022 | 1 | 0 |
| 2023 | 3 | 0 |
| 2024 | 1 | 0 |
| 2026 | 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 MQP? 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 MQP device
- #1 K261810 Vertiwedge® Intraosseous Systemscore 18.1 · 22 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K111294 | Santorini Spinal SystemSummary page 4…Intervertebral Body Fixation Orthosis (21 CFR 888.3060, Product Code MQP) Predicate Device(s) Primary Predicate: K2M SANTORINI Corpectomy Cage System (K111294) Additional Predicates: Ulrich Obelisc (K060416) DePuy X-Mesh (080568) DePuy Surgical Titanium Mes… | 2012 |
| * | K060416 | Obelisc Vertebral Body Replacement DeviceSummary page 4…ct Code MQP) Predicate Device(s) Primary Predicate: K2M SANTORINI Corpectomy Cage System (K111294) Additional Predicates: Ulrich Obelisc (K060416) DePuy X-Mesh (080568) DePuy Surgical Titanium Mesh (K003043) Device Description The CAPRI Corpectomy… | 2006 |
| * | K080568 | X-Mesh Expandable Cage SystemSummary page 4…ice(s) Primary Predicate: K2M SANTORINI Corpectomy Cage System (K111294) Additional Predicates: Ulrich Obelisc (K060416) DePuy X-Mesh (080568) DePuy Surgical Titanium Mesh (K003043) Device Description The CAPRI Corpectomy Cage System is a hollow tube s… | 2008 |
| * | K003043 | Surgical Titanium Mesh SystemSummary page 4…ORINI Corpectomy Cage System (K111294) Additional Predicates: Ulrich Obelisc (K060416) DePuy X-Mesh (080568) DePuy Surgical Titanium Mesh (K003043) Device Description The CAPRI Corpectomy Cage System is a hollow tube structure manufactured from Ti6Al4V ELI and C… | 2001 |
What descends from it? (12)
See all 122 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 30 years and passes through 8 companies; a new generation was cleared every 1.9 years on median.
- 3 of the 34 ancestors have a recall of any class.
- Of its descendants, K170055 (K2m, 2017) has gone furthest, with 11 descendants of its own.
- 4 other devices also cite its predicate K111294.
How does its category compare?
All MQP devicesMQP Spinal Vertebral Body Replacement Device: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · MQP
4in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · MQP
187in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MQP
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MQP
168in 2025
MAUDE reports naming product code MQP, 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 | 30 | 107 | 2 | 61 |
| 2008 | 17 | 47 | 0 | 76 |
| 2009 | 11 | 115 | 14 | 111 |
| 2010 | 6 | 174 | 2 | 166 |
| 2011 | 8 | 237 | 1 | 121 |
| 2012 | 7 | 82 | 2 | 141 |
| 2013 | 3 | 90 | 0 | 207 |
| 2014 | 5 | 125 | 0 | 216 |
| 2015 | 8 | 126 | 0 | 258 |
| 2016 | 0 | — | 0 | 129 |
| 2017 | 9 | 97 | 0 | 141 |
| 2018 | 6 | 152 | 0 | 130 |
| 2019 | 8 | 93 | 0 | 117 |
| 2020 | 3 | 103 | 15 | 157 |
| 2021 | 0 | — | 0 | 208 |
| 2022 | 1 | — | 1 | 137 |
| 2023 | 1 | — | 0 | 71 |
| 2024 | 4 | 187 | 0 | 98 |
| 2025 | 0 | — | 0 | 168 |
| 2026 | 3 | 102 | 0 | — |
What is it indicated for?
The CAPRI Corpectomy Cage System is a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) to replace collapsed, damaged, or unstable vertebral bodies due to tumor or trauma (ie. Fracture). The CAPRI Corpectomy System is designed to provide anterior spinal column support even in the absence of fusion for a prolonged period. The CAPRI device may be used with allograft or autograft.
For all the above indications the CAPRI implants are intended to be used with supplemental internal fixation appropriate for the implanted level, including K2M Pedicle Screw and Hook Systems, and K2M Spinal Plate Systems.
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/K142016 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142016: CAPRI.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142016
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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