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 Jul 6, 2018 as substantially equivalent to K172185 (Tyber Medical, LLC, 2017) and 4 other predicates after a 122-day review. Its family tree reaches back 19 generations to 1984. 6 later devices descend from it.
- Decided
- Jul 6, 2018
- Review
- 122 days
- Class
- Class II
- Product code
- ODP
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 19 generations to K841189 (1984). 270 ancestors in all, the oldest K792352 (1979). 6 later devices descend from it, 1 citing it directly.
- Root · 19 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 15 generations between
- 3 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 2 generations backK151773 CONCORDE Bullet Lumbar Interbody SystemMedos International SARL · 2015
- 1 generation backK162358 T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution…Synthes USA Products, LLC · 2016
- This deviceK180590 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
- Descendant · 3 generations on · 0 of its ownK240699 SCARLET® AC-TiSpineart SA · 2024
Show all 19 generations
- Root · 19 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 18 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 17 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 16 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 15 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 14 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 13 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 12 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 11 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 10 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 9 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 8 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 7 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 6 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- 5 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 4 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 3 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 2 generations backK151773 CONCORDE Bullet Lumbar Interbody SystemMedos International SARL · 2015
- 1 generation backK162358 T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution…Synthes USA Products, LLC · 2016
- This deviceK180590 Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC · 2018
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- 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
- K240699SCARLET® AC-TiSpineart SA · 2024 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −19 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −18 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −17 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −16 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −15 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −14 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −13 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −12 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −11 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −10 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −9 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −8 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −7 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| −6 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| −5 | K132505 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | 3 |
| −4 | K141217 | Acculif TL and PL Cage | Stryker Corporation | 2014 | 3 |
| −3 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| −2 | K151773 | CONCORDE Bullet Lumbar Interbody System | Medos International SARL | 2015 | — |
| −1 | K162358 | T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution System | Synthes USA Products, LLC | 2016 | — |
| 0 (this device) | 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 | — |
| +3 | K240699 | SCARLET® AC-Ti | Spineart SA | 2024 | — |
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 | 2 | 0 |
| 2001 | 10 | 0 |
| 2002 | 9 | 0 |
| 2003 | 15 | 0 |
| 2004 | 25 | 0 |
| 2005 | 16 | 0 |
| 2006 | 11 | 0 |
| 2007 | 15 | 0 |
| 2008 | 38 | 0 |
| 2009 | 23 | 0 |
| 2010 | 18 | 0 |
| 2011 | 16 | 0 |
| 2012 | 12 | 0 |
| 2013 | 13 | 0 |
| 2014 | 13 | 0 |
| 2015 | 5 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K172185 | Tyber Medical PT Interbody Spacer SystemSummary page 4…y fusion and Number device (21 CFR 888.3080, Class II) Product Code ODP and MAX Primary Predicate Tyber Medical PT Interbody Spacer System (172185) Device Additional Predicates DPS Concorde Bullet Lumbar Interbody (K151773), Aesculap Plasmapore XP Sp… | 2017 |
| * | K151773 | CONCORDE Bullet Lumbar Interbody SystemSummary page 4…ode ODP and MAX Primary Predicate Tyber Medical PT Interbody Spacer System (172185) Device Additional Predicates DPS Concorde Bullet Lumbar Interbody (K151773), Aesculap Plasmapore XP Spinal System (K132421), DPS T-PAL Spacer System (K162358) and… | 2015 |
| * | K132421 | Aesculap Peek XP Spinal Implant SystemSummary page 4…rbody Spacer System (172185) Device Additional Predicates DPS Concorde Bullet Lumbar Interbody (K151773), Aesculap Plasmapore XP Spinal System (K132421), DPS T-PAL Spacer System (K162358) and Medtronic Anatomic PEEK PTC Cervical Fusion System (K133653). Dev… | 2014 |
| * | K162358 | T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution SystemSummary page 4…Additional Predicates DPS Concorde Bullet Lumbar Interbody (K151773), Aesculap Plasmapore XP Spinal System (K132421), DPS T-PAL Spacer System (K162358) and Medtronic Anatomic PEEK PTC Cervical Fusion System (K133653). Device Description This submissio… | 2016 |
| * | K133653 | Anatomic Peek PTC Cervical Fusion SystemSummary page 4…ore XP Spinal System (K132421), DPS T-PAL Spacer System (K162358) and Medtronic Anatomic PEEK PTC Cervical Fusion System (K133653). Device Description This submission is to update language in the Indications for Use, and update la… | 2014 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K182284 | Tyber Medical PT Interbody Spacer | 2019 | 5 |
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 34 years and passes through 14 companies; a new generation was cleared every 11 months on median.
- 27 of the 270 ancestors have a recall of any class.
- Of its descendants, K182284 (Tyber Medical, LLC, 2019) has gone furthest, with 5 descendants of its own.
- 1 other device also cites its predicate K172185.
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. 2018, 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?
Cervical System Indications: The Tyber Medical PT Interbody Spacer 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…
Read the full statement (289 words)
Cervical System Indications:
The Tyber Medical PT Interbody Spacer 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 and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. When used as an interbody fusion device, supplemental fixation must be used.
Lumbar System Indications:
The Tyber Medical PT Interbody Spacer 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). DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. These patients may also have had a previous non-fusion spinal surgery at the involved spinal level(s). Additionally, the Tyber Medical PT Interbody System can be used in patients diagnosed with spinal deformities as an adjunct to fusion. Patients should have six weeks 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 autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. When used as interbody fusion devices these implants are intended for use with supplemental fixation systems cleared for use in the thoracolumbar spine.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180590 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180590: 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/K180590
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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