510(k) · Cleared
ClearedMega 5.5 Spine System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lsk Biopartners, Inc. · MNH Orthosis, Spondylolisthesis Spinal Fixation
Cleared on Jan 8, 2013 as substantially equivalent to K072436 (Bk Meditech, Co., Ltd., 2007) and 3 other predicates after a 56-day review. Its family tree reaches back 4 generations to 1995. 5 later devices descend from it.
- Decided
- Jan 8, 2013
- Review
- 56 days
- Class
- Class II
- Product code
- MNH
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 4 generations to K951116 (1995). 34 ancestors in all, the oldest K884263 (1988). 5 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK951116 Acromed Pedicle ScrewAcromed Corp. · 1995
- 3 generations backK963639 Acromed Pedicle ScrewAcromed Corp. · 1996
- 2 generations backK982511 Depuy Motech Moss Miami Spinal SystemsDepuy, Inc. · 1998
- 1 generation backK030383 Modification to Moss Miami Spinal System Polyaxial ScrewsDepuyacromed · 2003
- This deviceK123476 Mega 5.5 Spine SystemLsk Biopartners, Inc. · 2013
- Descendant · cites it directly · 4 of its ownK171497 Mikron Spinal Fixation SystemMikron Makina Sanayi Ticaret Co., Ltd. · 2017
- Descendant · 2 generations on · 3 of its ownK241657 MSFX Mikron Spinal Fixation SystemMikron Makina Sanayi VE Ticaret Ltd. Sti. · 2024
- Descendant · 3 generations on · 1 of its ownK243946 EffortMed Spinal Fixation SystemEffortmed, LLC · 2025
- Descendant · 4 generations on · 0 of its ownK254247 Osteomni Spinal Fixation SystemOsteomni, Inc. · 2026
- Descendant · 3 generations on · 0 of its ownK250092 HC Biologics Osteopoint Spinal Fixation SystemHC Biologics, LLC · 2025
Most influential descendants
Showing 5 of 5 · See all- K171497Mikron Spinal Fixation SystemMikron Makina Sanayi Ticaret Co., Ltd. · 2017 · cites it directly4descendants
- K241657MSFX Mikron Spinal Fixation SystemMikron Makina Sanayi VE Ticaret Ltd. Sti. · 2024 · 2 generations on3descendants
- K243946EffortMed Spinal Fixation SystemEffortmed, LLC · 2025 · 3 generations on1descendant
- K254247Osteomni Spinal Fixation SystemOsteomni, Inc. · 2026 · 4 generations on0descendants
- K250092HC Biologics Osteopoint Spinal Fixation SystemHC Biologics, LLC · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K951116 | Acromed Pedicle Screw | Acromed Corp. | 1995 | — |
| −3 | K963639 | Acromed Pedicle Screw | Acromed Corp. | 1996 | — |
| −2 | K982511 | Depuy Motech Moss Miami Spinal Systems | Depuy, Inc. | 1998 | — |
| −1 | K030383 | Modification to Moss Miami Spinal System Polyaxial Screws | Depuyacromed | 2003 | — |
| 0 (this device) | K123476 | Mega 5.5 Spine System | Lsk Biopartners, Inc. | 2013 | — |
| +1 | K171497 | Mikron Spinal Fixation System | Mikron Makina Sanayi Ticaret Co., Ltd. | 2017 | — |
| +2 | K241657 | MSFX Mikron Spinal Fixation System | Mikron Makina Sanayi VE Ticaret Ltd. Sti. | 2024 | — |
| +3 | K243946 | EffortMed Spinal Fixation System | Effortmed, LLC | 2025 | — |
| +4 | K254247 | Osteomni Spinal Fixation System | Osteomni, Inc. | 2026 | — |
| +3 | K250092 | HC Biologics Osteopoint Spinal Fixation System | HC Biologics, LLC | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 4 | 0 |
| 1996 | 4 | 0 |
| 1997 | 2 | 0 |
| 1998 | 4 | 0 |
| 1999 | 1 | 0 |
| 2000 | 5 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 3 | 0 |
| 2007 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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…nal principles and material composition when compared to the predicate device cleared under the f'ollowing submissions: * Mega Spine System (K072436, BK MEDITECI I Co., Ltd.) * OPTIMA TM Spinal System (K031595, U&l Corporation, America) * DELTA,… | 2007 |
| * | K031595 | U & I America Spinal Hook SystemSummary page 1…dicate device cleared under the f'ollowing submissions: * Mega Spine System (K072436, BK MEDITECI I Co., Ltd.) * OPTIMA TM Spinal System (K031595, U&l Corporation, America) * DELTA, Spinal Fusion System (K07 1857, Jemo Spine. LLC) * Moss Miami… | 2003 |
| * | K071857 | Delta Spinal Fusion SystemSummary page 1…ne System (K072436, BK MEDITECI I Co., Ltd.) * OPTIMA TM Spinal System (K031595, U&l Corporation, America) * DELTA, Spinal Fusion System (K07 1857, Jemo Spine. LLC) * Moss Miami Spinal System Polyaxial Screws (K030383, DePuy AcroMed, Inc)… | 2007 |
| * | K030383 | Modification to Moss Miami Spinal System Polyaxial ScrewsSummary page 1…K031595, U&l Corporation, America) * DELTA, Spinal Fusion System (K07 1857, Jemo Spine. LLC) * Moss Miami Spinal System Polyaxial Screws (K030383, DePuy AcroMed, Inc) K123476-… | 2003 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K171497 | Mikron Spinal Fixation System | 2017 | 4 |
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 18 years and passes through 4 companies; a new generation was cleared every 4.5 years on median.
- 4 of the 34 ancestors have a recall of any class.
- Of its descendants, K171497 (Mikron Makina Sanayi Ticaret Co., Ltd., 2017) has gone furthest, with 4 descendants of its own.
- 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. 2013, 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 Mega 5.5 Spine System is a pedicle screw system indicated for the treatment of severe Spondylolisthesis (Grade 3 and 4) of the L5-SI vertebra in skeletally mature patients receiving fusion by autogeneous 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 Mega 5.5 Spine System is intended to provide immobilization and stabilization of…
Read the full statement (123 words)
The Mega 5.5 Spine System is a pedicle screw system indicated for the treatment of severe Spondylolisthesis (Grade 3 and 4) of the L5-SI vertebra in skeletally mature patients receiving fusion by autogeneous 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 Mega 5.5 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 the thoracic, lumbar and sacral spine: degenerative Spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis. kyphosis, spinal turnor and failed previous fusion (pseudoarthrosis).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123476 · printed Nov 5, 2026
Cite this page
510(k) Report. “K123476: Mega 5.5 Spine System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K123476
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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