510(k) · Cleared
ClearedPalls M Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Korea Bone Bank Co., Ltd. · MNI Orthosis, Spinal Pedicle Fixation
Cleared on Mar 23, 2012 as substantially equivalent to K102574 (Korea Bone Bank Co., Ltd., 2011) after a 30-day review. Its family tree reaches back 6 generations to 2000. 1 later device descends from it.
- Decided
- Mar 23, 2012
- Review
- 30 days
- Class
- Class II
- Product code
- MNI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K000319 (2000). 11 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK000319 Ebi Xfix DFS SystemEbi, L.P. · 2000
- 5 generations backK020279 Forex Corporation, Optima, Spinal SystemForex Corp. · 2002 · Recalled
- 4 generations backK031585 U&I, Optima, Spinal SystemU&I Corp., America · 2003 · Recalled
- 3 generations backK053573 GSS Pedicle Screw SystemGS Medical Co., Ltd. · 2006
- 2 generations backK082509 Eos Spinal SystemKorea Bone Bank Co., Ltd. · 2008
- 1 generation backK102574 Palla M Spinal SystemKorea Bone Bank Co., Ltd. · 2011
- This deviceK120538 Palls M Spinal SystemKorea Bone Bank Co., Ltd. · 2012
- Descendant · cites it directly · 0 of its ownK140359 Maximis Spinal Fixation SystemValorem Surgical · 2015 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K140359Maximis Spinal Fixation SystemValorem Surgical · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K000319 | Ebi Xfix DFS System | Ebi, L.P. | 2000 | — |
| −5 | K020279 | Forex Corporation, Optima, Spinal System | Forex Corp. | 2002 | 4 |
| −4 | K031585 | U&I, Optima, Spinal System | U&I Corp., America | 2003 | 5 |
| −3 | K053573 | GSS Pedicle Screw System | GS Medical Co., Ltd. | 2006 | — |
| −2 | K082509 | Eos Spinal System | Korea Bone Bank Co., Ltd. | 2008 | — |
| −1 | K102574 | Palla M Spinal System | Korea Bone Bank Co., Ltd. | 2011 | — |
| 0 (this device) | K120538 | Palls M Spinal System | Korea Bone Bank Co., Ltd. | 2012 | — |
| +1 | K140359 | Maximis Spinal Fixation System | Valorem Surgical | 2015 | 144 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 4 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 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 |
|---|---|---|---|
| * | K102574 | Palla M Spinal SystemSummary page 1…as performed. Predicate Devices: The subject device is substantially equivalent to the following predicate devices: * Pallas M Spinal System (Korea Bone Bank Co., Ltd.; K 102574) KlaoJ;3… | 2011 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K140359 | Maximis Spinal Fixation System | 2015 | 0 |
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 12 years and passes through 5 companies; a new generation was cleared every 2.3 years on median.
- 2 of the 11 ancestors have a recall of any class.
- Of its descendants, K140359 (Valorem Surgical, 2015) has gone furthest, with 0 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. 2012, 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 Pallas M Spinal System is intended for posterior, noncervical pedlicle and non-pedicle fixation 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, kypbosis, spinal tumor and failed previous fusion (pseudarthrosis).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120538 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120538: Palls M Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120538
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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