510(k) · Decided
DecidedOptima ZS Transition Screw
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zimmer Spine, Inc. · MNI Orthosis, Spinal Pedicle Fixation
Cleared on Oct 5, 2007 after an 88-day review. The FDA summary names its predicate without a number. 4 later devices descend from it.
- Decided
- Oct 5, 2007
- Review
- 88 days
- Class
- Class II
- Product code
- MNI
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK071880 Optima ZS Transition ScrewZimmer Spine, Inc. · 2007
- Descendant · cites it directly · 2 of its ownK211027 Altus Spine Pedicle Screw SystemAltus Partners, LLC · 2022
- Descendant · 2 generations on · 1 of its ownK230766 Altus Spine Monaco Pedicle Screw SystemAltus Spine · 2023
- Descendant · 3 generations on · 0 of its ownK243419 Altus Spine Navigation SystemAltus Partners, LLC · 2025
- Descendant · cites it directly · 0 of its ownK132644 Lospa IS Pedicle Screw (Monoaxial & Polyaxial), Lospa IS Rod-…Corentec Co., Ltd. · 2013
Most influential descendants
Showing 4 of 4 · See all- K211027Altus Spine Pedicle Screw SystemAltus Partners, LLC · 2022 · cites it directly2descendants
- K230766Altus Spine Monaco Pedicle Screw SystemAltus Spine · 2023 · 2 generations on1descendant
- K243419Altus Spine Navigation SystemAltus Partners, LLC · 2025 · 3 generations on0descendants
- K132644Lospa IS Pedicle Screw (Monoaxial & Polyaxial), Lospa IS Rod- Straight (Standard), Lospa…Corentec Co., Ltd. · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K071880 | Optima ZS Transition Screw | Zimmer Spine, Inc. | 2007 | — |
| +1 | K211027 | Altus Spine Pedicle Screw System | Altus Partners, LLC | 2022 | — |
| +2 | K230766 | Altus Spine Monaco Pedicle Screw System | Altus Spine | 2023 | — |
| +3 | K243419 | Altus Spine Navigation System | Altus Partners, LLC | 2025 | — |
| +1 | K132644 | Lospa IS Pedicle Screw (Monoaxial & Polyaxial), Lospa IS Rod- Straight… | Corentec Co., Ltd. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 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 MNI? 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? (1)
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 |
|---|---|---|---|
| * | — | OPTIMA ZS Spinal System Named without a submission number |
What descends from it? (4)
2 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?
- Of its descendants, K211027 (Altus Partners, LLC, 2022) has gone furthest, with 2 descendants of its own.
How does its category compare?
All MNI devicesMNI Orthosis, Spinal Pedicle Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · MNI
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · MNI
168in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MNI
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MNI
80in 2025
MAUDE reports naming product code MNI, 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 | 20 | 82 | 26 | 83 |
| 2008 | 23 | 64 | 8 | 108 |
| 2009 | 18 | 86 | 3 | 138 |
| 2010 | 16 | 74 | 1 | 126 |
| 2011 | 17 | 111 | 0 | 146 |
| 2012 | 19 | 75 | 1 | 200 |
| 2013 | 14 | 77 | 4 | 824 |
| 2014 | 6 | 104 | 0 | 301 |
| 2015 | 12 | 54 | 1 | 260 |
| 2016 | 7 | 168 | 0 | 117 |
| 2017 | 1 | — | 0 | 247 |
| 2018 | 0 | — | 1 | 134 |
| 2019 | 0 | — | 0 | 188 |
| 2020 | 0 | — | 0 | 115 |
| 2021 | 0 | — | 0 | 270 |
| 2022 | 0 | — | 0 | 214 |
| 2023 | 0 | — | 0 | 122 |
| 2024 | 0 | — | 0 | 114 |
| 2025 | 0 | — | 0 | 80 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The OPTIMATM ZS Spinal System is a posterior pedicle screw fixation system indicated for the treatment of severe spondylolisthesis, (Grade 3 and 4), of the L5-S1 vertebra in skeletally-mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine with removal of implants after the attainment of a solid fusion. In addition, The OPTIMATM ZS Spinal System is intended to provide immobilization and…
Read the full statement (179 words)
The OPTIMATM ZS Spinal System is a posterior pedicle screw fixation system indicated for the treatment of severe spondylolisthesis, (Grade 3 and 4), of the L5-S1 vertebra in skeletally-mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine with removal of implants after the attainment of a solid fusion.
In addition, The OPTIMATM ZS Spinal 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 the thoracic, lumbar and sacral spine:
· Degenerative spondylolisthesis with objective evidence of neurological impairment
· Fracture of the vertebral body
· Dislocation
* Scoliosis
* Kyphosis
* Spinal tumor
* Failed previous fusion (Pseudoarthrosis).
When the Zimmer GmbH Dynesys® Spinal System and the OPTIMATMZS Spinal System are used on contiguous levels, they must be used with the Zimmer GmbH ZimmeP DTOTM Implant, rod-cord combination implant, and the OPTIMATm ZS Transition Screw. The indications for use for each level is as specified for each system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071880 · printed Nov 4, 2026
Cite this page
510(k) Report. “K071880: Optima ZS Transition Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071880
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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