510(k) · Cleared
ClearedProvidence Cervical Cage
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Providence Medical Technology, Inc. · ODP Intervertebral Fusion Device With Bone Graft, Cervical
Cleared on May 24, 2013 as substantially equivalent to P980048 (Sulzer Spine-Tech, 2001) and 4 other predicates after a 253-day review. Its family tree reaches back 11 generations to 1984. 1 later device descends from it.
- Decided
- May 24, 2013
- Review
- 253 days
- Class
- Class II
- Product code
- ODP
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 11 generations to K841189 (1984). 50 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 11 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 7 generations between
- 3 generations backK083857 LDR Spine Roi-C ImplantLdr Spine USA · 2009
- 2 generations backK091088 LDR Spine Cervical Interbody Fusion SystemLdr Spine USA · 2009
- 1 generation backK111123 Varilift Cervical Interbody Fusion SystemWenzel Spine · 2011
- This deviceK122801 Providence Cervical CageProvidence Medical Technology, Inc. · 2013
- Descendant · cites it directly · 0 of its ownK161642 CAVUX™ Cervical CageProvidence Medical Technology, Inc. · 2016
Show all 11 generations
- Root · 11 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 10 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 9 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 8 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 7 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 6 generations backK033109 Ellys and Aurys Vertebral Body ReplacementsScient'X · 2004
- 5 generations backK043479 MC+ Partial VBRLdr Spine USA · 2005
- 4 generations backK080728 LDR Spine Roi-C ImplantLdr Spine USA · 2008
- 3 generations backK083857 LDR Spine Roi-C ImplantLdr Spine USA · 2009
- 2 generations backK091088 LDR Spine Cervical Interbody Fusion SystemLdr Spine USA · 2009
- 1 generation backK111123 Varilift Cervical Interbody Fusion SystemWenzel Spine · 2011
- This deviceK122801 Providence Cervical CageProvidence Medical Technology, Inc. · 2013
Most influential descendants
Showing 1 of 1 · See all- K161642CAVUX™ Cervical CageProvidence Medical Technology, Inc. · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −10 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −9 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −8 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −7 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −6 | K033109 | Ellys and Aurys Vertebral Body Replacements | Scient'X | 2004 | — |
| −5 | K043479 | MC+ Partial VBR | Ldr Spine USA | 2005 | — |
| −4 | K080728 | LDR Spine Roi-C Implant | Ldr Spine USA | 2008 | — |
| −3 | K083857 | LDR Spine Roi-C Implant | Ldr Spine USA | 2009 | — |
| −2 | K091088 | LDR Spine Cervical Interbody Fusion System | Ldr Spine USA | 2009 | — |
| −1 | K111123 | Varilift Cervical Interbody Fusion System | Wenzel Spine | 2011 | — |
| 0 (this device) | K122801 | Providence Cervical Cage | Providence Medical Technology, Inc. | 2013 | — |
| +1 | K161642 | CAVUX™ Cervical Cage | Providence Medical Technology, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 8 | 0 |
| 2002 | 5 | 0 |
| 2003 | 1 | 0 |
| 2004 | 4 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 3 | 0 |
| 2008 | 4 | 0 |
| 2009 | 7 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 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 ODP? 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? (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 |
|---|---|---|---|
| * | P980048 | Bak/Cervical (Bak/C) Interbody Fusion SystemSummary page 1…P: Intervertebral Fusion Device With Bone Graft, Cervical 87, Orthopedics Predicate Device(s): Zimmer BAKO/C (P980048B) Wenzel Varitift-C (K111123) RSB Spine Interplat… | 2001 |
| * | K111123 | Varilift Cervical Interbody Fusion SystemSummary page 1…87, Orthopedics Predicate Device(s): Zimmer BAKO/C (P980048B) Wenzel Varitift-C (K111123) RSB Spine Interplate C (K092070) Signur Rabea Ti… | 2011 |
| * | K092070 | Interplate CSummary page 1…Zimmer BAKO/C (P980048B) Wenzel Varitift-C (K111123) RSB Spine Interplate C (K092070) Signur Rabea Ti (K082848) Medyssey C7 Anterior C… | 2009 |
| * | K082848 | Nubic and Rabea DevicesSummary page 1…Wenzel Varitift-C (K111123) RSB Spine Interplate C (K092070) Signur Rabea Ti (K082848) Medyssey C7 Anterior Cervical Cage (K121320) Device Information A. Intended Use PMT Cer… | 2009 |
| * | K121320 | C7 Anterior Cervical Intervertebral Fusion CageSummary page 1…pine Interplate C (K092070) Signur Rabea Ti (K082848) Medyssey C7 Anterior Cervical Cage (K121320) Device Information A. Intended Use PMT Cervical Cage is indicated for use in skeletally mature patients with degenerative disc… | 2012 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K161642 | CAVUX™ Cervical Cage | 2016 | 0 |
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 29 years and passes through 8 companies; a new generation was cleared every 1.5 years on median.
- 5 of the 50 ancestors have a recall of any class.
- Of its descendants, K161642 (Providence Medical Technology, Inc., 2016) has gone furthest, with 0 descendants of its own.
- 53 other devices also cite its predicate P980048.
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. 2013, 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?
PMT Cervical Cage is indicated for use in skeletally mature patients with degenerative disc disease (DOD) of the cervical spine (C3-C7) with accompanying radicular symptoms at one disc level. ODD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received at least six weeks of non-operative treatment prior to treatment with the device. Devices are intended to be used with autogenous bone graft and supplemental fixation, such as an anterior plating system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122801 · printed Nov 4, 2026
Cite this page
510(k) Report. “K122801: Providence Cervical Cage.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K122801
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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