510(k) · Cleared
ClearedUlc Spinal Pedicle Screw System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Otis Biotech Co., Ltd. · MNH Orthosis, Spondylolisthesis Spinal Fixation
Cleared on Oct 26, 2009 as substantially equivalent to K072436 (Bk Meditech, Co., Ltd., 2007) and 3 other predicates after a 375-day review. Its family tree reaches back 4 generations to 2000.
- Decided
- Oct 26, 2009
- Review
- 375 days
- Class
- Class II
- Product code
- MNH
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 4 generations to K000319 (2000). 16 ancestors in all, the oldest K962628 (1997). No later device cites it as a predicate yet.
- Root · 4 generations backK000319 Ebi Xfix DFS SystemEbi, L.P. · 2000
- 3 generations backK020279 Forex Corporation, Optima, Spinal SystemForex Corp. · 2002 · Recalled
- 2 generations backK024096 Optima, Spinal SystemU&I Corp., America · 2003 · Recalled
- 1 generation backK071857 Delta Spinal Fusion SystemJemo Spine, LLC · 2007
- This deviceK083077 Ulc Spinal Pedicle Screw SystemOtis Biotech Co., Ltd. · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K000319 | Ebi Xfix DFS System | Ebi, L.P. | 2000 | — |
| −3 | K020279 | Forex Corporation, Optima, Spinal System | Forex Corp. | 2002 | 4 |
| −2 | K024096 | Optima, Spinal System | U&I Corp., America | 2003 | 3 |
| −1 | K071857 | Delta Spinal Fusion System | Jemo Spine, LLC | 2007 | — |
| 0 (this device) | K083077 | Ulc Spinal Pedicle Screw System | Otis Biotech Co., Ltd. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2000 | 4 | 0 |
| 2001 | 2 | 0 |
| 2003 | 2 | 0 |
| 2005 | 2 | 0 |
| 2007 | 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 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? (4)
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 |
|---|---|---|---|
| * | K072436 | Mega Spine SystemSummary page 1…Fixation. 3. Substantial Equivalence Predicate Legally Marketed Devices BK Meditech Co., Ltd., MEGA spine system - MNI MNH - K072436 Jemo Spine, LLC., DELTA T M spinal fusion system - MNI MNH KWQ - K071857 Stryker Spine, Xia ® Spinal system - M… | 2007 |
| * | K071857 | Delta Spinal Fusion SystemSummary page 1…Legally Marketed Devices BK Meditech Co., Ltd., MEGA spine system - MNI MNH - K072436 Jemo Spine, LLC., DELTA T M spinal fusion system - MNI MNH KWQ - K071857 Stryker Spine, Xia ® Spinal system - MNI MNH KWP KWQ - K053115 Artificial Joint Research Center… | 2007 |
| * | K053115 | Xia Spinal SystemSummary page 1…tem - MNI MNH - K072436 Jemo Spine, LLC., DELTA T M spinal fusion system - MNI MNH KWQ - K071857 Stryker Spine, Xia ® Spinal system - MNI MNH KWP KWQ - K053115 Artificial Joint Research Center 5-1 OTIS Biotech co., Ltd.… | 2005 |
| * | K051971 | Optima Spinal SystemSummary page 2…otification 510(k) ULC spinalpedicle screw system 5. 510(k) Summary U&I Corporation, OPTIMATM Spinal System - MNI MNH KWQ - K051971 The substantial equivalence of this device is based on equivalence in intended use, materials, designs and operati… | 2005 |
What descends from it?
No later submission names this one as a predicate yet.
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 9 years and passes through 5 companies; a new generation was cleared every 2.3 years on median.
- 3 of the 16 ancestors have a recall of any class.
- 2 other devices also cite its predicate K072436.
How does its category compare?
All MNH devicesMNH Orthosis, Spondylolisthesis Spinal Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 ULC spinal pedicle screw systems are intended for posterior and non-cervical pedicle fixation 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 (L3 to sacrum) with removal of the implants after the attainment of a solid fusion. In addition, the ULC is intended to provide immobilization and…
Read the full statement (123 words)
The ULC spinal pedicle screw systems are intended for posterior and non-cervical pedicle fixation 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 (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.
In addition, the ULC 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, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudarthrosis).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083077 · printed Nov 4, 2026
Cite this page
510(k) Report. “K083077: Ulc Spinal Pedicle Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K083077
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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