510(k) · Cleared
ClearedTyber Medical PT Interbody Spacer System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tyber Medical, LLC · ODP Intervertebral Fusion Device With Bone Graft, Cervical
Cleared on Dec 21, 2017 as substantially equivalent to K130573 (Tyber Medical, LLC, 2013) and 4 other predicates after a 154-day review. Its family tree reaches back 14 generations to 2001. 7 later devices descend from it.
- Decided
- Dec 21, 2017
- Review
- 154 days
- Class
- Class II
- Product code
- ODP
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 14 generations to K003155 (2001). 114 ancestors in all, the oldest K792352 (1979). 7 later devices descend from it, 2 citing it directly.
- Root · 14 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 10 generations between
- 3 generations backK073285 Peek Prevail Cervical Interbody DeviceMedtronic Sofamor Danek USA, Inc. · 2008
- 2 generations backK100214 Cornerstone PSR Cervical Interbody Fusion DeviceMedtronic Sofamor Danek · 2010
- 1 generation backK120275 Synthes Acis/Vertebral Spacer CRSynthes (Usa), LLC · 2012
- This deviceK172185 Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC · 2017
- Descendant · cites it directly · 6 of its ownK180590 Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC · 2018
- Descendant · cites it directly · 5 of its ownK182284 Tyber Medical PT Interbody SpacerTyber Medical, LLC · 2019
- Descendant · 2 generations on · 1 of its ownK230583 Tryptik TiSpineart SA · 2023
- Descendant · 2 generations on · 1 of its ownK192897 icotec Cervical CageIcotec AG · 2020
- Descendant · 2 generations on · 0 of its ownK250605 EVOL® ha – Hyper C Cervical Interbody Fusion SystemCutting Edge Spine, LLC · 2025
Show all 14 generations
- Root · 14 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 13 generations backK012254 VBROsteotech, Inc. · 2001
- 12 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 11 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 10 generations backK030601 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
- 9 generations backK040536 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 8 generations backK041556 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 7 generations backK043561 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 6 generations backK060719 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006
- 5 generations backK062133 Modification to Verte-Stack Spinal SystemMedtronic Spinal and Biologics Div · 2006
- 4 generations backK070173 Verte-Stack Spinal SystemMedtronic Sofamor Danek, Inc. · 2007
- 3 generations backK073285 Peek Prevail Cervical Interbody DeviceMedtronic Sofamor Danek USA, Inc. · 2008
- 2 generations backK100214 Cornerstone PSR Cervical Interbody Fusion DeviceMedtronic Sofamor Danek · 2010
- 1 generation backK120275 Synthes Acis/Vertebral Spacer CRSynthes (Usa), LLC · 2012
- This deviceK172185 Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC · 2017
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K180590Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC · 2018 · cites it directly6descendants
- K182284Tyber Medical PT Interbody SpacerTyber Medical, LLC · 2019 · cites it directly5descendants
- K230583Tryptik TiSpineart SA · 2023 · 2 generations on1descendant
- K192897icotec Cervical CageIcotec AG · 2020 · 2 generations on1descendant
- K250605EVOL® ha – Hyper C Cervical Interbody Fusion SystemCutting Edge Spine, LLC · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K003155 | Vertebral Body Replacement | Osteotech, Inc. | 2001 | — |
| −13 | K012254 | VBR | Osteotech, Inc. | 2001 | — |
| −12 | K021791 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −11 | K023570 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −10 | K030601 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2003 | — |
| −9 | K040536 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −8 | K041556 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −7 | K043561 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −6 | K060719 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −5 | K062133 | Modification to Verte-Stack Spinal System | Medtronic Spinal and Biologics Div | 2006 | — |
| −4 | K070173 | Verte-Stack Spinal System | Medtronic Sofamor Danek, Inc. | 2007 | — |
| −3 | K073285 | Peek Prevail Cervical Interbody Device | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −2 | K100214 | Cornerstone PSR Cervical Interbody Fusion Device | Medtronic Sofamor Danek | 2010 | — |
| −1 | K120275 | Synthes Acis/Vertebral Spacer CR | Synthes (Usa), LLC | 2012 | — |
| 0 (this device) | K172185 | Tyber Medical PT Interbody Spacer System | Tyber Medical, LLC | 2017 | — |
| +1 | K180590 | Tyber Medical PT Interbody Spacer System | Tyber Medical, LLC | 2018 | — |
| +1 | K182284 | Tyber Medical PT Interbody Spacer | Tyber Medical, LLC | 2019 | — |
| +2 | K230583 | Tryptik Ti | Spineart SA | 2023 | — |
| +2 | K192897 | icotec Cervical Cage | Icotec AG | 2020 | — |
| +2 | K250605 | EVOL® ha – Hyper C Cervical Interbody Fusion System | Cutting Edge Spine, LLC | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1984 | 1 | 0 |
| 1996 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 9 | 0 |
| 2002 | 6 | 0 |
| 2003 | 10 | 0 |
| 2004 | 17 | 0 |
| 2005 | 11 | 0 |
| 2006 | 4 | 0 |
| 2007 | 9 | 0 |
| 2008 | 11 | 0 |
| 2009 | 8 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K130573 | Tyber Medical Interbody System; Acif, Alif, Plif, Tlif, DlifSummary page 4…vertebral body fusion device and Number (21 CFR 888.3080) Product Code ODP and MAX Predicate Device Tyber Medical Interbody Spacer System (K130573) Additional Predicates Synthes ACIS (K120275), DePuy Spine Concorde Curve (K101923), DePuy Spine Later… | 2013 |
| * | K120275 | Synthes Acis/Vertebral Spacer CRSummary page 4…(21 CFR 888.3080) Product Code ODP and MAX Predicate Device Tyber Medical Interbody Spacer System (K130573) Additional Predicates Synthes ACIS (K120275), DePuy Spine Concorde Curve (K101923), DePuy Spine Lateral System (K090899); Aesculap ASpace, CESpace, P… | 2012 |
| * | K101923 | Concorde Curve SystemSummary page 4…ODP and MAX Predicate Device Tyber Medical Interbody Spacer System (K130573) Additional Predicates Synthes ACIS (K120275), DePuy Spine Concorde Curve (K101923), DePuy Spine Lateral System (K090899); Aesculap ASpace, CESpace, Prospace, T-Spa… | 2010 |
| * | K090899 | Depuy Spine Lateral SystemSummary page 4…erbody Spacer System (K130573) Additional Predicates Synthes ACIS (K120275), DePuy Spine Concorde Curve (K101923), DePuy Spine Lateral System (K090899); Aesculap ASpace, CESpace, Prospace, T-Space (K071983) Device Description This submission is to add… | 2009 |
| * | K071983 | Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace, Prospace, T-SpaceSummary page 4…DePuy Spine Concorde Curve (K101923), DePuy Spine Lateral System (K090899); Aesculap ASpace, CESpace, Prospace, T-Space (K071983) Device Description This submission is to add additional shape configurations, with an optional opti… | 2008 |
What descends from it? (7)
2 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 16 years and passes through 7 companies; a new generation was cleared every 10 months on median.
- 12 of the 114 ancestors have a recall of any class.
- Of its descendants, K180590 (Tyber Medical, LLC, 2018) has gone furthest, with 6 descendants of its own.
- 10 other devices also cite its predicate K130573.
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?
Lumbar System Indications The Tyber Medical PT Interbody System is indicated for use as intervertebral body fusion devices in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine (L2-S1). Patients should have six months of non-operative treatment prior to surgery. These implants are…
Read the full statement (214 words)
Lumbar System Indications
The Tyber Medical PT Interbody System is indicated for use as intervertebral body fusion devices in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine (L2-S1). Patients should have six months of non-operative treatment prior to surgery. These implants are used to facilitate fusion in the lumbar spine and are placed via either a posterior, transforaminal, lateral or anterior approach using autogenous bone. When used as interbody fusion devices these implants are intended for use with supplemental fixation systems cleared for use in the thoracolumbar spine.
Cervical System Indications
The Tyber Medical PT Interbody System is indicated for use as an intervertebral body fusion device in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one level of the cervical spine with accompanying radicular symptoms. Patients should have six weeks of non-operative treatment prior to surgery. Cervical implants are used to facilitate fusion in the cervical spine (C2-T1) and are placed via an anterior approach using autogenous bone. When used as an interbody fusion device, supplemental fixation must be used.
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/K172185 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172185: Tyber Medical PT Interbody Spacer System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172185
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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