510(k) · Cleared
ClearedTiger Spine System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Corelink, LLC · MNH Orthosis, Spondylolisthesis Spinal Fixation
Cleared on May 25, 2011 as substantially equivalent to K990118 (Scien'Tx USA, Inc., 1999) and 4 other predicates after a 111-day review. Its family tree reaches back 6 generations to 1990. 83 later devices descend from it.
- Decided
- May 25, 2011
- Review
- 111 days
- Class
- Class II
- Product code
- MNH
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 6 generations to K901587 (1990). 34 ancestors in all. 83 later devices descend from it, 6 citing it directly.
- Root · 6 generations backK901587 TSRH Sacral L-ConnectorDanek Medical, Inc. · 1990
- 5 generations backK950099 Synergy (TM) TI Posterior Spinal SystemBuckman Co., Inc. · 1997
- 4 generations backK973836 Synergy 6.35MM SS Rod with Screws for Anterior Use, Part of the…Cross Medical Products, Inc. · 1998
- 3 generations backK980484 Aesculap Spine System EvolutionAesculap, Inc. · 1998
- 2 generations backK990118 Isobar Spinal SystemScien'Tx USA, Inc. · 1999
- 1 generation backK013444 Isobar Spinal SystemScien'Tx USA, Inc. · 2001
- This deviceK110321 Tiger Spine SystemCorelink, LLC · 2011
- Descendant · cites it directly · 81 of its ownK113058 Tiger Spine SystemCorelink, LLC · 2012
- Descendant · cites it directly · 41 of its ownK120696 Tiger Spine SystemCorelink, LLC · 2012
- Descendant · cites it directly · 40 of its ownK131250 Tiger Spine SystemCorelink, LLC · 2013
- Descendant · 2 generations on · 30 of its ownK151977 icotec Pedicle SystemIcotec AG · 2016
- Descendant · 2 generations on · 29 of its ownK190545 VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG · 2019 · Recalled
Showing 5 of 83 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 83 · See all- K113058Tiger Spine SystemCorelink, LLC · 2012 · cites it directly81descendants
- K120696Tiger Spine SystemCorelink, LLC · 2012 · cites it directly41descendants
- K131250Tiger Spine SystemCorelink, LLC · 2013 · cites it directly40descendants
- K151977icotec Pedicle SystemIcotec AG · 2016 · 2 generations on30descendants
- K190545VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG · 2019 · 2 generations on29descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K901587 | TSRH Sacral L-Connector | Danek Medical, Inc. | 1990 | — |
| −5 | K950099 | Synergy (TM) TI Posterior Spinal System | Buckman Co., Inc. | 1997 | — |
| −4 | K973836 | Synergy 6.35MM SS Rod with Screws for Anterior Use, Part of the Cross… | Cross Medical Products, Inc. | 1998 | — |
| −3 | K980484 | Aesculap Spine System Evolution | Aesculap, Inc. | 1998 | — |
| −2 | K990118 | Isobar Spinal System | Scien'Tx USA, Inc. | 1999 | — |
| −1 | K013444 | Isobar Spinal System | Scien'Tx USA, Inc. | 2001 | — |
| 0 (this device) | K110321 | Tiger Spine System | Corelink, LLC | 2011 | — |
| +1 | K113058 | Tiger Spine System | Corelink, LLC | 2012 | — |
| +1 | K120696 | Tiger Spine System | Corelink, LLC | 2012 | — |
| +1 | K131250 | Tiger Spine System | Corelink, LLC | 2013 | — |
| +2 | K151977 | icotec Pedicle System | Icotec AG | 2016 | — |
| +2 | K190545 | VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0 | Icotec AG | 2019 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1992 | 5 | 0 |
| 1993 | 2 | 0 |
| 1994 | 3 | 0 |
| 1995 | 3 | 0 |
| 1996 | 4 | 0 |
| 1997 | 3 | 0 |
| 1998 | 3 | 0 |
| 1999 | 1 | 0 |
| 2004 | 2 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 3 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 3 | 0 |
| 2016 | 3 | 0 |
| 2017 | 3 | 0 |
| 2018 | 3 | 0 |
| 2019 | 4 | 0 |
| 2020 | 6 | 0 |
| 2021 | 2 | 0 |
| 2022 | 5 | 0 |
| 2023 | 13 | 0 |
| 2024 | 15 | 0 |
| 2025 | 12 | 0 |
| 2026 | 7 | 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 MNH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K990118 | Isobar Spinal SystemSummary page 1…section 888.3070 Class 11 3. Predicate or legally marketed devices which are substantially equivalent: ISOBAR (Scient'x - K990118/K013444) ZODIACTM Polyaxial Spinal Fixation System (Alphatec - K042673) Array Spinal System (Biomet - K033312/K… | 1999 |
| * | K013444 | Isobar Spinal SystemSummary page 1…888.3070 Class 11 3. Predicate or legally marketed devices which are substantially equivalent: ISOBAR (Scient'x - K990118/K013444) ZODIACTM Polyaxial Spinal Fixation System (Alphatec - K042673) Array Spinal System (Biomet - K033312/K061563)… | 2001 |
| * | K042673 | Zodiac Polyaxial Spinal Fixation SystemSummary page 1…legally marketed devices which are substantially equivalent: ISOBAR (Scient'x - K990118/K013444) ZODIACTM Polyaxial Spinal Fixation System (Alphatec - K042673) Array Spinal System (Biomet - K033312/K061563) 4. Description of the device: The TIGERTM Spine System is com… | 2004 |
| * | K033312 | Ebi Top Loading Mas Spinal Fixation SystemSummary page 1…y equivalent: ISOBAR (Scient'x - K990118/K013444) ZODIACTM Polyaxial Spinal Fixation System (Alphatec - K042673) Array Spinal System (Biomet - K033312/K061563) 4. Description of the device: The TIGERTM Spine System is comprised of polyaxial pedicle screws, rods and cro… | 2004 |
| * | K061563 | Ebi Array Spinal SystemSummary page 1…lent: ISOBAR (Scient'x - K990118/K013444) ZODIACTM Polyaxial Spinal Fixation System (Alphatec - K042673) Array Spinal System (Biomet - K033312/K061563) 4. Description of the device: The TIGERTM Spine System is comprised of polyaxial pedicle screws, rods and crosslinks.… | 2006 |
| † | K000536 | Synthes Anterior CSLP System | 2000 |
| † | K884263 | Rogozinski Spinal System | 1988 |
| † | K072022 | Valeo Pedicle Screw Spinal System | 2007 |
What descends from it? (83)
See all 836 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 21 years and passes through 6 companies; a new generation was cleared every 2.7 years on median.
- 1 of the 34 ancestors has a recall of any class.
- Of its descendants, K113058 (Corelink, LLC, 2012) has gone furthest, with 81 descendants of its own.
- 13 other devices also cite its predicate K990118.
How does its category compare?
All MNH devicesMNH Orthosis, Spondylolisthesis Spinal Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · MNH
8in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · MNH
93in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MNH
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MNH
89in 2025
MAUDE reports naming product code MNH, 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 | 5 | 123 | 0 | 18 |
| 2008 | 13 | 65 | 0 | 30 |
| 2009 | 13 | 151 | 7 | 45 |
| 2010 | 10 | 106 | 0 | 59 |
| 2011 | 17 | 171 | 0 | 107 |
| 2012 | 7 | 93 | 1 | 433 |
| 2013 | 10 | 124 | 1 | 464 |
| 2014 | 12 | 140 | 0 | 286 |
| 2015 | 10 | 99 | 0 | 152 |
| 2016 | 8 | 93 | 1 | 216 |
| 2017 | 0 | — | 0 | 174 |
| 2018 | 0 | — | 0 | 129 |
| 2019 | 0 | — | 0 | 403 |
| 2020 | 0 | — | 0 | 432 |
| 2021 | 0 | — | 0 | 531 |
| 2022 | 0 | — | 0 | 265 |
| 2023 | 0 | — | 0 | 121 |
| 2024 | 0 | — | 0 | 302 |
| 2025 | 0 | — | 0 | 89 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The TIGER'" Spine System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion…
Read the full statement (122 words)
The TIGER'" Spine System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
When used as a pedicle screw system, the TIGER' m Spine System is intended for the treatment of severe spondylolisthesis (Grade 3 and 4) of the LS-S1 vertebrae in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110321 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110321: Tiger Spine System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110321
Report an extraction error
Are you the manufacturer?
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