510(k) · Cleared
ClearedKepler II
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Orbbo Surgical, LLC · ODP Intervertebral Fusion Device With Bone Graft, Cervical
Cleared on Apr 7, 2017 as substantially equivalent to K112801 (Qualgenix, 2012) and 1 other predicate after a 137-day review. Its family tree reaches back 5 generations to 2009. 1 of the 15 devices in its family, counting itself, has a Class I recall.
- Decided
- Apr 7, 2017
- Review
- 137 days
- Class
- Class II
- Product code
- ODP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K091531 (2009). 14 ancestors in all, the oldest P950002 (1996). No later device cites it as a predicate yet. 1 of the 15 devices in this family, counting this one, has a Class I recall.
- Root · 5 generations backK091531 Choice Spine Cervical Interbody Spacer System Choice Spine Cervical…Choice Spine, Llp · 2009
- 4 generations backK101171 Orthovita Peek SpacerOrthovita, Inc. · 2011
- 3 generations backK120486 Avs as Peek SpacerStryker Spine · 2012
- 2 generations backK142251 AVS AS PEEK SpacerStryker Corporation · 2014
- 1 generation backK161407 Ascential IBD PEEKc SpacerStryker Spine · 2016
- This deviceK163265 Kepler IIOrbbo Surgical, LLC · 2017
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 |
|---|---|---|---|---|---|
| −5 | K091531 | Choice Spine Cervical Interbody Spacer System Choice Spine Cervical Interbody… | Choice Spine, Llp | 2009 | — |
| −4 | K101171 | Orthovita Peek Spacer | Orthovita, Inc. | 2011 | — |
| −3 | K120486 | Avs as Peek Spacer | Stryker Spine | 2012 | — |
| −2 | K142251 | AVS AS PEEK Spacer | Stryker Corporation | 2014 | — |
| −1 | K161407 | Ascential IBD PEEKc Spacer | Stryker Spine | 2016 | — |
| 0 (this device) | K163265 | Kepler II | Orbbo Surgical, LLC | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2008 | 3 | 1 |
| 2009 | 1 | 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? (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 |
|---|---|---|---|
| * | K112801 | Ayers Rock Cervical CageSummary page 5…s of manufacture (identical) e Structural support mechanism (identical) Table 5-1 Predicate Devices 510k Trade or Proprietary or Model | Manufacturer Type Number Name K112801 Ayers Rock Qualgenix Primary K161407 Ascential IBD PEEK® Spacer Stryker Spine Additional PERFORMANCE TESTING Orbbo, LLC. Kepler… | 2012 |
| * | K161407 | Ascential IBD PEEKc SpacerSummary page 5…ural support mechanism (identical) Table 5-1 Predicate Devices 510k Trade or Proprietary or Model | Manufacturer Type Number Name K112801 Ayers Rock Qualgenix Primary K161407 Ascential IBD PEEK® Spacer Stryker Spine Additional PERFORMANCE TESTING Orbbo, LLC. Kepler II was evaluated to demonstrate equiv… | 2016 |
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 8 years and passes through 5 companies; a new generation was cleared every 1.6 years on median.
- 1 of the 14 ancestors has a recall of any class; 1 has a Class I recall.
- 1 other device also cites its predicate K112801.
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. 2017, 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 Kepler II is indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one level from C2-T1. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history of radiographic studies. These patients should have had 6 weeks of non-operative treatment. The Kepler II implants are to be used with autogenous bone graft and implanted via an open, anterior approach. The Kepler II Cervical Cage is to be used with supplemental fixation.
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/K163265 · printed Nov 4, 2026
Cite this page
510(k) Report. “K163265: Kepler II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K163265
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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