510(k) · Cleared
ClearedTranscorp Acif System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Transcorp, Inc. · ODP Intervertebral Fusion Device With Bone Graft, Cervical
Cleared on Sep 13, 2010 as substantially equivalent to K081730 (Alphatec Spine, Inc., 2008) and 1 other predicate after a 367-day review. Its family tree reaches back 1 generation to 2001. 4 later devices descend from it.
- Decided
- Sep 13, 2010
- Review
- 367 days
- Class
- Class II
- Product code
- ODP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to P980048 (2001). 2 ancestors in all. 4 later devices descend from it, 3 citing it directly.
- Root · 1 generation backP980048 Bak/Cervical (Bak/C) Interbody Fusion SystemSulzer Spine-Tech · 2001
- This deviceK092794 Transcorp Acif SystemTranscorp, Inc. · 2010
- Descendant · cites it directly · 1 of its ownK110585 Captiva Spine Fuselox Cervical CageCaptiva Spine, Inc. · 2011
- Descendant · 2 generations on · 0 of its ownK181229 TirboLOX-C Cervical IBFDCaptiva Spine, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK142586 Captiva Spine FuselOX Cervical IBF SystemCaptiva Spine · 2015
- Descendant · cites it directly · 0 of its ownK121178 Transcorp Acif SystemTranscorp, Inc. · 2013
Most influential descendants
Showing 4 of 4 · See all- K110585Captiva Spine Fuselox Cervical CageCaptiva Spine, Inc. · 2011 · cites it directly1descendant
- K181229TirboLOX-C Cervical IBFDCaptiva Spine, Inc. · 2018 · 2 generations on0descendants
- K142586Captiva Spine FuselOX Cervical IBF SystemCaptiva Spine · 2015 · cites it directly0descendants
- K121178Transcorp Acif SystemTranscorp, Inc. · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | P980048 | Bak/Cervical (Bak/C) Interbody Fusion System | Sulzer Spine-Tech | 2001 | — |
| 0 (this device) | K092794 | Transcorp Acif System | Transcorp, Inc. | 2010 | — |
| +1 | K110585 | Captiva Spine Fuselox Cervical Cage | Captiva Spine, Inc. | 2011 | — |
| +2 | K181229 | TirboLOX-C Cervical IBFD | Captiva Spine, Inc. | 2018 | — |
| +1 | K142586 | Captiva Spine FuselOX Cervical IBF System | Captiva Spine | 2015 | — |
| +1 | K121178 | Transcorp Acif System | Transcorp, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 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? (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 |
|---|---|---|---|
| * | K081730 | Novel Cervical Spinal Spacer SystemSummary page 1…vertebral Body Fusion Device Classification: 21 CFR Section 888.3080, Product Code ODP, Class II Predicate Devices: K081 730 Alphatec Novel Spinal Spacer System P980048 BAKIC Vista Cervical Interbody Fusion Device Device Description:… | 2008 |
| * | P980048 | Bak/Cervical (Bak/C) Interbody Fusion SystemSummary page 1…tion 888.3080, Product Code ODP, Class II Predicate Devices: K081 730 Alphatec Novel Spinal Spacer System P980048 BAKIC Vista Cervical Interbody Fusion Device Device Description: The Transcorp Anterior Cervical Intervertebral Fusion (… | 2001 |
What descends from it? (4)
3 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?
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. 2010, 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 Transcorp ACIF System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine at one disc level. DIDD is defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies. Transcorp ACIF implants are used to facilitate fusion in the cervical spine and are placed via an anterior approach at the 03 to C7 disc levels using autogenous bone graft. Patients should have at least six weeks of non-operative treatment prior to treatment with an intervertebral body fusion device. The device must be used with supplemental fixation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092794 · printed Nov 5, 2026
Cite this page
510(k) Report. “K092794: Transcorp Acif System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K092794
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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