510(k) · Cleared
ClearedCAPRI Corpectomy Cage System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
K2m · MQP Spinal Vertebral Body Replacement Device
Cleared on Apr 13, 2017 as substantially equivalent to K142016 (K2m, Inc., 2014) and 4 other predicates after a 97-day review. Its family tree reaches back 20 generations to 1984. 1 of the 226 devices in its family, counting itself, has a Class I recall. 11 later devices descend from it.
- Decided
- Apr 13, 2017
- Review
- 97 days
- Class
- Class II
- Product code
- MQP
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 20 generations to K841189 (1984). 214 ancestors in all, the oldest K792352 (1979). 11 later devices descend from it, 2 citing it directly. 1 of the 226 devices in this family, counting this one, has a Class I recall.
- Root · 20 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 16 generations between
- 3 generations backK143616 AccuLIF TL and PL CageStryker Corporation · 2015 · Recalled
- 2 generations backK152304 Tritanium PL CageStryker · 2015 · Recalled
- 1 generation backK160125 Cascadia Interbody SystemK2m · 2016
- This deviceK170055 CAPRI Corpectomy Cage SystemK2m · 2017
- Descendant · cites it directly · 10 of its ownK171704 CAPRI Corpectomy Cage SystemK2m · 2017
- Descendant · cites it directly · 9 of its ownK180665 SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage SystemK2m, LLC · 2018
- Descendant · 2 generations on · 2 of its ownK211320 CAPRI Corpectomy Cage SystemK2m, Inc. · 2022
- Descendant · 2 generations on · 1 of its ownK221490 Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL…Stryker Spine · 2023
- Descendant · 2 generations on · 1 of its ownK202637 F3D Corpectomy SystemCorelink, LLC · 2020
Show all 20 generations
- Root · 20 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 19 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 18 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 17 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 16 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 15 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 14 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 13 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 12 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 11 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 10 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 9 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 8 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 7 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- 6 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 5 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 4 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 3 generations backK143616 AccuLIF TL and PL CageStryker Corporation · 2015 · Recalled
- 2 generations backK152304 Tritanium PL CageStryker · 2015 · Recalled
- 1 generation backK160125 Cascadia Interbody SystemK2m · 2016
- This deviceK170055 CAPRI Corpectomy Cage SystemK2m · 2017
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K073202 Ardis Spacer3 generations back · 2008
Most influential descendants
Showing 5 of 11 · See all- K171704CAPRI Corpectomy Cage SystemK2m · 2017 · cites it directly10descendants
- K180665SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage SystemK2m, LLC · 2018 · cites it directly9descendants
- K211320CAPRI Corpectomy Cage SystemK2m, Inc. · 2022 · 2 generations on2descendants
- K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine · 2023 · 2 generations on1descendant
- K202637F3D Corpectomy SystemCorelink, LLC · 2020 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −20 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −19 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −18 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −17 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −16 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −15 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −14 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −13 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −12 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −11 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −10 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −9 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −8 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| −7 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| −6 | K132505 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | 3 |
| −5 | K141217 | Acculif TL and PL Cage | Stryker Corporation | 2014 | 3 |
| −4 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| −3 | K143616 | AccuLIF TL and PL Cage | Stryker Corporation | 2015 | 4 |
| −2 | K152304 | Tritanium PL Cage | Stryker | 2015 | 1 |
| −1 | K160125 | Cascadia Interbody System | K2m | 2016 | — |
| 0 (this device) | K170055 | CAPRI Corpectomy Cage System | K2m | 2017 | — |
| +1 | K171704 | CAPRI Corpectomy Cage System | K2m | 2017 | — |
| +1 | K180665 | SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage System | K2m, LLC | 2018 | — |
| +2 | K211320 | CAPRI Corpectomy Cage System | K2m, Inc. | 2022 | — |
| +2 | K221490 | Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved… | Stryker Spine | 2023 | — |
| +2 | K202637 | F3D Corpectomy System | Corelink, LLC | 2020 | — |
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 | 1 | 0 |
| 2001 | 10 | 0 |
| 2002 | 8 | 0 |
| 2003 | 15 | 0 |
| 2004 | 22 | 0 |
| 2005 | 11 | 0 |
| 2006 | 7 | 0 |
| 2007 | 12 | 0 |
| 2008 | 34 | 1 |
| 2009 | 18 | 0 |
| 2010 | 9 | 0 |
| 2011 | 15 | 0 |
| 2012 | 9 | 0 |
| 2013 | 5 | 0 |
| 2014 | 9 | 0 |
| 2015 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 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.
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 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? (5)
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 |
|---|---|---|---|
| * | K142016 | CAPRISummary page 4…Name(s): Spinal Intervertebral Body Fixation Orthosis (21 CFR 888.3060, Product Code MQP) Predicate Device(s) Primary Predicate: K2M CAPRI Corpectomy Cage System (K142016) Additional Predicates: K2M Santorini Corpectomy Cage System (K111294) K2M Cascadia Interbody System (K150481, K160125)… | 2014 |
| * | K111294 | Santorini Spinal SystemSummary page 4…duct Code MQP) Predicate Device(s) Primary Predicate: K2M CAPRI Corpectomy Cage System (K142016) Additional Predicates: K2M Santorini Corpectomy Cage System (K111294) K2M Cascadia Interbody System (K150481, K160125) Ulrich VBR (K012254) Device Description The CAPRI Corpectomy System… | 2012 |
| * | K150481 | Cascadia Interbody SystemSummary page 4…Predicate: K2M CAPRI Corpectomy Cage System (K142016) Additional Predicates: K2M Santorini Corpectomy Cage System (K111294) K2M Cascadia Interbody System (K150481, K160125) Ulrich VBR (K012254) Device Description The CAPRI Corpectomy System implants are vertebral body replacement devi… | 2015 |
| * | K160125 | Cascadia Interbody SystemSummary page 4…: K2M CAPRI Corpectomy Cage System (K142016) Additional Predicates: K2M Santorini Corpectomy Cage System (K111294) K2M Cascadia Interbody System (K150481, K160125) Ulrich VBR (K012254) Device Description The CAPRI Corpectomy System implants are vertebral body replacement devices that… | 2016 |
| * | K012254 | VBRSummary page 4…y Cage System (K142016) Additional Predicates: K2M Santorini Corpectomy Cage System (K111294) K2M Cascadia Interbody System (K150481, K160125) Ulrich VBR (K012254) Device Description The CAPRI Corpectomy System implants are vertebral body replacement devices that are designed in a variety… | 2001 |
What descends from it? (11)
See all 112 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 33 years and passes through 13 companies; a new generation was cleared every 10 months on median.
- 26 of the 214 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K171704 (K2m, 2017) has gone furthest, with 10 descendants of its own.
- 1 other device also cites its predicate K142016.
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. 2017, 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 to L5) to replace collapsed, damaged, or unstable vertebral bodies due to tumor or trauma (i.e., fracture). The CAPRI Corpectomy Cage 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 as stated in the FDA summary.
https://510kreport.com/device/K170055 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170055: CAPRI Corpectomy Cage System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170055
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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