510(k) · Cleared
ClearedTyber Medical Interbody System; Acif, Alif, Plif, Tlif, Dlif
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 Sep 30, 2013 as substantially equivalent to K112036 (X-Spine Systems, Inc., 2011) and 6 other predicates after a 210-day review. Its family tree reaches back 11 generations to 2001. 251 later devices descend from it.
- Decided
- Sep 30, 2013
- Review
- 210 days
- Class
- Class II
- Product code
- ODP
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 11 generations to K003155 (2001). 60 ancestors in all, the oldest K841189 (1984). 251 later devices descend from it, 11 citing it directly.
- Root · 11 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 7 generations between
- 3 generations backK051205 Stryker Spine Avs Asl Peek SpacerStryker Spine · 2005
- 2 generations backK060762 Aesculap Peek Vertebral Body Replacement SystemAesculap, Inc. · 2006
- 1 generation backK071983 Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace…Aesculap Implant Systems, Inc. · 2008 · Recalled
- This deviceK130573 Tyber Medical Interbody System; Acif, Alif, Plif, Tlif, DlifTyber Medical, LLC · 2013
- Descendant · cites it directly · 227 of its ownK133967 Interbody Cage SystemAurora Spine · 2014
- Descendant · 2 generations on · 210 of its ownK143578 SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer…Globus Medical, Inc. · 2016
- Descendant · 3 generations on · 117 of its ownK161223 TransContinental® M Spacers and InterContinental® Plate-SpacersGlobus Medical, Inc. · 2016
- Descendant · 3 generations on · 109 of its ownK170157 INDEPENDENCE® SpacersGlobus Medical, Inc. · 2017
- Descendant · 3 generations on · 97 of its ownK181357 PATRIOT® Lumbar Spacers, SUSTAIN® SpacersGlobus Medical, Inc. · 2018
Show all 11 generations
- Root · 11 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 10 generations backK012254 VBROsteotech, Inc. · 2001
- 9 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 8 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 7 generations backK031780 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
- 6 generations backK040731 Stryker Spine Vertebral SpacerStryker Spine · 2004
- 5 generations backK042571 Stryker Spine Avs TL Peek SpacerStryker Spine · 2005
- 4 generations backK050624 Stryker Spine Avs PL Peek SpacerStryker Spine · 2005
- 3 generations backK051205 Stryker Spine Avs Asl Peek SpacerStryker Spine · 2005
- 2 generations backK060762 Aesculap Peek Vertebral Body Replacement SystemAesculap, Inc. · 2006
- 1 generation backK071983 Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace…Aesculap Implant Systems, Inc. · 2008 · Recalled
- This deviceK130573 Tyber Medical Interbody System; Acif, Alif, Plif, Tlif, DlifTyber Medical, LLC · 2013
Showing 5 of 251 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 251 · See all- K133967Interbody Cage SystemAurora Spine · 2014 · cites it directly227descendants
- K143578SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS Spacers…Globus Medical, Inc. · 2016 · 2 generations on210descendants
- K161223TransContinental® M Spacers and InterContinental® Plate-SpacersGlobus Medical, Inc. · 2016 · 3 generations on117descendants
- K170157INDEPENDENCE® SpacersGlobus Medical, Inc. · 2017 · 3 generations on109descendants
- K181357PATRIOT® Lumbar Spacers, SUSTAIN® SpacersGlobus Medical, Inc. · 2018 · 3 generations on97descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K003155 | Vertebral Body Replacement | Osteotech, Inc. | 2001 | — |
| −10 | K012254 | VBR | Osteotech, Inc. | 2001 | — |
| −9 | K021791 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −8 | K023570 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −7 | K031780 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2003 | — |
| −6 | K040731 | Stryker Spine Vertebral Spacer | Stryker Spine | 2004 | — |
| −5 | K042571 | Stryker Spine Avs TL Peek Spacer | Stryker Spine | 2005 | — |
| −4 | K050624 | Stryker Spine Avs PL Peek Spacer | Stryker Spine | 2005 | — |
| −3 | K051205 | Stryker Spine Avs Asl Peek Spacer | Stryker Spine | 2005 | — |
| −2 | K060762 | Aesculap Peek Vertebral Body Replacement System | Aesculap, Inc. | 2006 | — |
| −1 | K071983 | Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace, Prospace… | Aesculap Implant Systems, Inc. | 2008 | 1 |
| 0 (this device) | K130573 | Tyber Medical Interbody System; Acif, Alif, Plif, Tlif, Dlif | Tyber Medical, LLC | 2013 | — |
| +1 | K133967 | Interbody Cage System | Aurora Spine | 2014 | — |
| +2 | K143578 | SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS… | Globus Medical, Inc. | 2016 | — |
| +3 | K161223 | TransContinental® M Spacers and InterContinental® Plate-Spacers | Globus Medical, Inc. | 2016 | — |
| +3 | K170157 | INDEPENDENCE® Spacers | Globus Medical, Inc. | 2017 | — |
| +3 | K181357 | PATRIOT® Lumbar Spacers, SUSTAIN® Spacers | Globus Medical, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1996 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 7 | 0 |
| 2002 | 5 | 0 |
| 2003 | 8 | 0 |
| 2004 | 6 | 0 |
| 2005 | 5 | 0 |
| 2007 | 4 | 0 |
| 2008 | 2 | 0 |
| 2009 | 3 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 3 | 0 |
| 2017 | 8 | 0 |
| 2018 | 12 | 0 |
| 2019 | 9 | 0 |
| 2020 | 21 | 0 |
| 2021 | 21 | 0 |
| 2022 | 28 | 0 |
| 2023 | 38 | 0 |
| 2024 | 42 | 0 |
| 2025 | 38 | 0 |
| 2026 | 28 | 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? (7)
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 |
|---|---|---|---|
| * | K112036 | Calix PC Spinal Implant SystemSummary page 1…Name Intervertebral body fusion device (21 CFR 888.3080) and Number Product Code ODP and MAX Predicate Devices* I. X-SPINE; Calix - K 112036 2. SPINAL ELEMENTS; Lucent and Lucent Magnum - KI 110632 3. DEP… | 2011 |
| * | K110632 | Lucent or Lucent MagnumSummary page 1…ODP and MAX Predicate Devices* I. X-SPINE; Calix - K 112036 2. SPINAL ELEMENTS; Lucent and Lucent Magnum - KI 110632 3. DEPUY SPINE; Bengal. Concorde. Cougar, Devex. and Leopard -… | 2012 |
| * | K081917 | Depuy Spine Bengal, Concorde, Cougar, Devex and Leopard SystemsSummary page 1…Lucent and Lucent Magnum - KI 110632 3. DEPUY SPINE; Bengal. Concorde. Cougar, Devex. and Leopard - K081917 4. AESCULAP; ASpace, CESpace. Prospace, T-Space - K07 1983 5. S… | 2009 |
| * | K071983 | Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace, Prospace, T-SpaceSummary page 1…al. Concorde. Cougar, Devex. and Leopard - K081917 4. AESCULAP; ASpace, CESpace. Prospace, T-Space - K07 1983 5. SYNTHES; Opal and Oracle Spacer - K072791 6. SYNTHES; T-Pal… | 2008 |
| * | K072791 | Oracle Spacer, Opal SpacerSummary page 1…K081917 4. AESCULAP; ASpace, CESpace. Prospace, T-Space - K07 1983 5. SYNTHES; Opal and Oracle Spacer - K072791 6. SYNTHES; T-Pal - K 100089 7. CHOICE SPINE; STEATH PEEK Cervi… | 2007 |
| * | K100089 | Synthes T-Pal SpacerSummary page 1…CESpace. Prospace, T-Space - K07 1983 5. SYNTHES; Opal and Oracle Spacer - K072791 6. SYNTHES; T-Pal - K 100089 7. CHOICE SPINE; STEATH PEEK Cervical Fusion Device- K 120570 Device Description The Tyb… | 2010 |
| * | K120570 | Choice Spine Vertebral Body Replacement (VBR) Device SystemSummary page 1…acle Spacer - K072791 6. SYNTHES; T-Pal - K 100089 7. CHOICE SPINE; STEATH PEEK Cervical Fusion Device- K 120570 Device Description The Tyber Medical Interbody System, manufactured from PEEK-Optima* consist… | 2012 |
What descends from it? (251)
See all 25111 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K133967 | Interbody Cage System | 2014 | 227 |
| K150847 | Foundation Interbody Devices | 2015 | 29 |
| K172185 | Tyber Medical PT Interbody Spacer System | 2017 | 7 |
| K181589 | Curiteva Lumbar Interbody Fusion System | 2018 | 6 |
| K182284 | Tyber Medical PT Interbody Spacer | 2019 | 5 |
| K201367 | FlareHawk TiHawk9 Interbody Fusion System | 2020 | 2 |
| K160699 | VIRTU Lumbar Spacer System | 2016 | 2 |
| K193457 | AUDERE Lumbar Spacer System | 2020 | 1 |
| K183092 | Kuros TLIF Cage | 2019 | 0 |
| K162693 | VertebraLINK Fusion Platform | 2017 | 0 |
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 12 years and passes through 6 companies; a new generation was cleared every 9 months on median.
- 7 of the 60 ancestors have a recall of any class.
- Of its descendants, K133967 (Aurora Spine, 2014) has gone furthest, with 227 descendants of its own.
- 11 other devices also cite its predicate K112036.
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. 2013, 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 Tyber Medical interbody Systems are 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…
Read the full statement (208 words)
The Tyber Medical interbody Systems are 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.
The Tyber Medical Cervical Interbody Systems 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 as stated in the FDA summary.
https://510kreport.com/device/K130573 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130573: Tyber Medical Interbody System; Acif, Alif, Plif, Tlif, Dlif.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130573
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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