510(k) · Cleared
ClearedTyber Medical PT Interbody Spacer
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 Jan 18, 2019 as substantially equivalent to K180590 (Tyber Medical, LLC, 2018) and 4 other predicates after a 148-day review. Its family tree reaches back 20 generations to 1984. 5 later devices descend from it.
- Decided
- Jan 18, 2019
- Review
- 148 days
- Class
- Class II
- Product code
- ODP
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 20 generations to K841189 (1984). 318 ancestors in all, the oldest K792352 (1979). 5 later devices descend from it, 3 citing it directly.
- Root · 20 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 16 generations between
- 3 generations backK151773 CONCORDE Bullet Lumbar Interbody SystemMedos International SARL · 2015
- 2 generations backK162358 T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution…Synthes USA Products, LLC · 2016
- 1 generation backK180590 Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC · 2018
- This deviceK182284 Tyber Medical PT Interbody SpacerTyber Medical, LLC · 2019
- Descendant · cites it directly · 1 of its ownK230583 Tryptik TiSpineart SA · 2023
- Descendant · cites it directly · 1 of its ownK192897 icotec Cervical CageIcotec AG · 2020
- Descendant · cites it directly · 0 of its ownK250605 EVOL® ha – Hyper C Cervical Interbody Fusion SystemCutting Edge Spine, LLC · 2025
- Descendant · 2 generations on · 0 of its ownK240699 SCARLET® AC-TiSpineart SA · 2024
- Descendant · 2 generations on · 0 of its ownK232792 icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF…Icotec AG · 2024
Show all 20 generations
- Root · 20 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 19 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 18 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 17 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 16 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 15 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 14 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 13 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 12 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 11 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 10 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 9 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 8 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 7 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- 6 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 5 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 4 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 3 generations backK151773 CONCORDE Bullet Lumbar Interbody SystemMedos International SARL · 2015
- 2 generations backK162358 T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution…Synthes USA Products, LLC · 2016
- 1 generation backK180590 Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC · 2018
- This deviceK182284 Tyber Medical PT Interbody SpacerTyber Medical, LLC · 2019
Most influential descendants
Showing 5 of 5 · See all- K230583Tryptik TiSpineart SA · 2023 · cites it directly1descendant
- K192897icotec Cervical CageIcotec AG · 2020 · cites it directly1descendant
- K250605EVOL® ha – Hyper C Cervical Interbody Fusion SystemCutting Edge Spine, LLC · 2025 · cites it directly0descendants
- K240699SCARLET® AC-TiSpineart SA · 2024 · 2 generations on0descendants
- K232792icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec…Icotec AG · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −20 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −19 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −18 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −17 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −16 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −15 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −14 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −13 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −12 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −11 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −10 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −9 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −8 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| −7 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| −6 | K132505 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | 3 |
| −5 | K141217 | Acculif TL and PL Cage | Stryker Corporation | 2014 | 3 |
| −4 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| −3 | K151773 | CONCORDE Bullet Lumbar Interbody System | Medos International SARL | 2015 | — |
| −2 | K162358 | T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution System | Synthes USA Products, LLC | 2016 | — |
| −1 | K180590 | Tyber Medical PT Interbody Spacer System | Tyber Medical, LLC | 2018 | — |
| 0 (this device) | K182284 | Tyber Medical PT Interbody Spacer | Tyber Medical, LLC | 2019 | — |
| +1 | K230583 | Tryptik Ti | Spineart SA | 2023 | — |
| +1 | K192897 | icotec Cervical Cage | Icotec AG | 2020 | — |
| +1 | K250605 | EVOL® ha – Hyper C Cervical Interbody Fusion System | Cutting Edge Spine, LLC | 2025 | — |
| +2 | K240699 | SCARLET® AC-Ti | Spineart SA | 2024 | — |
| +2 | K232792 | icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage… | Icotec AG | 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 | 26 | 0 |
| 2005 | 17 | 0 |
| 2006 | 13 | 0 |
| 2007 | 15 | 0 |
| 2008 | 42 | 0 |
| 2009 | 29 | 0 |
| 2010 | 23 | 0 |
| 2011 | 23 | 0 |
| 2012 | 16 | 0 |
| 2013 | 17 | 0 |
| 2014 | 19 | 0 |
| 2015 | 8 | 0 |
| 2016 | 4 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K180590 | Tyber Medical PT Interbody Spacer SystemSummary page 4…n Name Intervertebral body fusion device and Number (21 CFR 888.3080) Product Code ODP Primary Predicate Tyber Medical PT Interbody System (K180590), Additional Predicate Nuvasive (K163491), Globus (K173722), Tyber Medical Interbody Devices System (K130573) an… | 2018 |
| * | K163491 | NuVasive CoRoent Small Interbody SystemSummary page 4…and Number (21 CFR 888.3080) Product Code ODP Primary Predicate Tyber Medical PT Interbody System (K180590), Additional Predicate Nuvasive (K163491), Globus (K173722), Tyber Medical Interbody Devices System (K130573) and Tyber Medical PT Interbody Line Extension… | 2017 |
| * | K173722 | PATRIOT COLONIAL Spacer, SUSTAIN SpacerSummary page 4…(21 CFR 888.3080) Product Code ODP Primary Predicate Tyber Medical PT Interbody System (K180590), Additional Predicate Nuvasive (K163491), Globus (K173722), Tyber Medical Interbody Devices System (K130573) and Tyber Medical PT Interbody Line Extension… | 2018 |
| * | K130573 | Tyber Medical Interbody System; Acif, Alif, Plif, Tlif, DlifSummary page 4…ate Tyber Medical PT Interbody System (K180590), Additional Predicate Nuvasive (K163491), Globus (K173722), Tyber Medical Interbody Devices System (K130573) and Tyber Medical PT Interbody Line Extension (K172185) Device Description This submission is to add… | 2013 |
| * | K172185 | Tyber Medical PT Interbody Spacer SystemSummary page 4…vasive (K163491), Globus (K173722), Tyber Medical Interbody Devices System (K130573) and Tyber Medical PT Interbody Line Extension (K172185) Device Description This submission is to add additional ACIF configurations to the Tyber Medical PT I… | 2017 |
What descends from it? (5)
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?
- The line of descent spans 35 years and passes through 14 companies; a new generation was cleared every 11 months on median.
- 32 of the 318 ancestors have a recall of any class.
- Of its descendants, K230583 (Spineart SA, 2023) has gone furthest, with 1 descendant of its own.
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. 2019, 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 Cervical Interbody Spacers are interbody fusion devices indicated at one or more levels of the cervical spine C2-T1 in patients with cervical disc disease, instability, trauma including fractures, deformity defined as kyphosis, lordosis, or scoliosis, cervical spondylotic myelopathy, spinal stenosis, and failed previous fusion. Cervical disc disease is defined as intractable radiculopathy and/or…
Read the full statement (134 words)
Cervical System Indications:
The Tyber Medical PT Cervical Interbody Spacers are interbody fusion devices indicated at one or more levels of the cervical spine C2-T1 in patients with cervical disc disease, instability, trauma including fractures, deformity defined as kyphosis, lordosis, or scoliosis, cervical spondylotic myelopathy, spinal stenosis, and failed previous fusion. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment.
Tyber Medical PT Cervical Interbody spacers are to be filled with autograft bone and/or allogenic bone graft composed of cancellous, cortical, and/or corticocancellous bone. These devices are intended to be used with supplemental fixation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K182284 · printed Nov 5, 2026
Cite this page
510(k) Report. “K182284: Tyber Medical PT Interbody Spacer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K182284
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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