510(k) · Cleared
Recalled · Class II · 2009Hydralok System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Altiva Corp. · MNH Orthosis, Spondylolisthesis Spinal Fixation
Cleared on Jul 19, 2005 after a 68-day review. The FDA summary names no predicate by number. 29 later devices descend from it. It has been recalled once.
- Decided
- Jul 19, 2005
- Review
- 68 days
- Class
- Class II
- Product code
- MNH
- Recalls
- 1
- Predicates
- 0
29 later devices descend from it, 3 citing it directly.
- This deviceK051216 Hydralok SystemAltiva Corp. · 2005
- Descendant · cites it directly · 17 of its ownK100956 Spondy Spinal Fixation SystemAllure Spine LLC · 2010
- Descendant · 2 generations on · 16 of its ownK111115 Captiva Spine Caplox II Spinal Fixation SystemCaptiva Spine, Inc. · 2011
- Descendant · 3 generations on · 15 of its ownK120292 Caplox II Pedicle Screw SystemCaptiva Spine, Inc. · 2012 · Recalled
- Descendant · 3 generations on · 14 of its ownK122332 Towerlox Pedicle Screw SystemCaptiva Spine · 2012
- Descendant · cites it directly · 9 of its ownK102870 Exactech Proliant Polyaxial Pedicle Screw SystemExactech, Inc. · 2011
Showing 5 of 29 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 29 · See all- K100956Spondy Spinal Fixation SystemAllure Spine LLC · 2010 · cites it directly17descendants
- K111115Captiva Spine Caplox II Spinal Fixation SystemCaptiva Spine, Inc. · 2011 · 2 generations on16descendants
- K120292Caplox II Pedicle Screw SystemCaptiva Spine, Inc. · 2012 · 3 generations on15descendants
- K122332Towerlox Pedicle Screw SystemCaptiva Spine · 2012 · 3 generations on14descendants
- K102870Exactech Proliant Polyaxial Pedicle Screw SystemExactech, Inc. · 2011 · cites it directly9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K051216 | Hydralok System | Altiva Corp. | 2005 | — |
| +1 | K100956 | Spondy Spinal Fixation System | Allure Spine LLC | 2010 | — |
| +2 | K111115 | Captiva Spine Caplox II Spinal Fixation System | Captiva Spine, Inc. | 2011 | — |
| +3 | K120292 | Caplox II Pedicle Screw System | Captiva Spine, Inc. | 2012 | 1 |
| +3 | K122332 | Towerlox Pedicle Screw System | Captiva Spine | 2012 | — |
| +1 | K102870 | Exactech Proliant Polyaxial Pedicle Screw System | Exactech, Inc. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 4 | 0 |
| 2017 | 1 | 0 |
| 2018 | 3 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2023 | 3 | 0 |
| 2024 | 2 | 0 |
| 2025 | 2 | 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?
The FDA summary names no predicate by number.
What descends from it? (29)
See all 293 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 6, 2009 | Class II | Z-2059-2015 | Device Design | Incorrect thread form on the screw. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K100956 (Allure Spine LLC, 2010) has gone furthest, with 17 descendants of its own.
How does its category compare?
All MNH devicesMNH Orthosis, Spondylolisthesis Spinal Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 HydraLok System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: • degenerative spondylolisthesis with objective evidence of neurological impairment, • fracture, • dislocation, • scoliosis, • kyphosis, • spinal tumor and • failed previous fusion (pseudoarthrosis) In addition, when…
Read the full statement (128 words)
The HydraLok System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine:
• degenerative spondylolisthesis with objective evidence of neurological impairment,
• fracture,
• dislocation,
• scoliosis,
• kyphosis,
• spinal tumor and
• failed previous fusion (pseudoarthrosis)
In addition, when used as a pedicle screw fixation system, the HydraLok System is intended for skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra, who are receiving fusion by autogenous bone graft only having the device attached to the lumbar and sacral spine (L3 and below), who are having the device removed after the development of a solid fusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051216 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051216: Hydralok System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051216
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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