510(k) · Cleared
ClearedPass 2 Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medicrea · MNI Orthosis, Spinal Pedicle Fixation
Cleared on Oct 6, 2006 as substantially equivalent to K982987 (Synthes Spine, 1998) and 2 other predicates after a 72-day review. Its family tree reaches back 3 generations to 2000. 146 later devices descend from it.
- Decided
- Oct 6, 2006
- Review
- 72 days
- Class
- Class II
- Product code
- MNI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K001024 (2000). 10 ancestors in all, the oldest K955348 (1996). 146 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK001024 Pass Spinal SystemEncore Orthopedics, Inc. · 2000
- 2 generations backK012175 Pass Spinal SystemEncore Orthopedics, Inc. · 2001
- 1 generation backK032094 Passmed Spinal SystemMedicrea · 2003
- This deviceK062136 Pass 2 Spinal SystemMedicrea · 2006
- Descendant · cites it directly · 133 of its ownK110497 Pass LP Spinal SystemMedicrea International · 2011 · Recalled
- Descendant · 2 generations on · 132 of its ownK123138 Pass LP Spinal SystemMedicrea International · 2013
- Descendant · 3 generations on · 84 of its ownK142798 PASS LP Spinal SystemMedicrea International SA · 2015
- Descendant · 4 generations on · 83 of its ownK152968 Arsenal Spinal Fixation SystemAlphatec Spine, Inc. · 2015
- Descendant · 5 generations on · 75 of its ownK161363 Arsenal Spinal Fixation SystemAlphatec Spine, Inc. · 2016
Showing 5 of 146 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 146 · See all- K110497Pass LP Spinal SystemMedicrea International · 2011 · cites it directly133descendants
- K123138Pass LP Spinal SystemMedicrea International · 2013 · 2 generations on132descendants
- K142798PASS LP Spinal SystemMedicrea International SA · 2015 · 3 generations on84descendants
- K152968Arsenal Spinal Fixation SystemAlphatec Spine, Inc. · 2015 · 4 generations on83descendants
- K161363Arsenal Spinal Fixation SystemAlphatec Spine, Inc. · 2016 · 5 generations on75descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K001024 | Pass Spinal System | Encore Orthopedics, Inc. | 2000 | — |
| −2 | K012175 | Pass Spinal System | Encore Orthopedics, Inc. | 2001 | — |
| −1 | K032094 | Passmed Spinal System | Medicrea | 2003 | — |
| 0 (this device) | K062136 | Pass 2 Spinal System | Medicrea | 2006 | — |
| +1 | K110497 | Pass LP Spinal System | Medicrea International | 2011 | 1 |
| +2 | K123138 | Pass LP Spinal System | Medicrea International | 2013 | — |
| +3 | K142798 | PASS LP Spinal System | Medicrea International SA | 2015 | — |
| +4 | K152968 | Arsenal Spinal Fixation System | Alphatec Spine, Inc. | 2015 | — |
| +5 | K161363 | Arsenal Spinal Fixation System | Alphatec Spine, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 2 | 0 |
| 2013 | 4 | 0 |
| 2014 | 1 | 0 |
| 2015 | 5 | 0 |
| 2016 | 7 | 0 |
| 2017 | 8 | 0 |
| 2018 | 8 | 0 |
| 2019 | 3 | 0 |
| 2020 | 6 | 0 |
| 2021 | 6 | 0 |
| 2022 | 13 | 0 |
| 2023 | 15 | 0 |
| 2024 | 19 | 0 |
| 2025 | 24 | 0 |
| 2026 | 25 | 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? (3)
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 |
|---|---|---|---|
| * | K982987 | Synthes Posterior Universal Spinal SystemSummary page 1…MNi, MNH 21Rsection 888.3070 Device panel Orthopedic Legally marketed predicate UISS (Synthes)= K(982987 devices MOSS MIAMI (Depuy Spine)= K(964024 PASSMed (MEDICREA)=… | 1998 |
| * | K964024 | Depuy Motech Titanium Moss Miami Spinal SystemSummary page 1…e panel Orthopedic Legally marketed predicate UISS (Synthes)= K(982987 devices MOSS MIAMI (Depuy Spine)= K(964024 PASSMed (MEDICREA)= K(032094 Sbmittr MEDICREA® Technologies… | 1997 |
| * | K032094 | Passmed Spinal SystemSummary page 1…nd as other devices commercially available. 5. SUBSTANTIAL EQUIVALENCE The PASS 2 Spinal System is similar to the UISS (1(892987), the MOSS MIAMI (1(964024) and PASSMed (K032094) distributed by Synthes, Depuy and Medicrea respectively Page vii === Page… | 2003 |
What descends from it? (146)
See all 1463 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?
- The line of descent spans 6 years and passes through 2 companies; a new generation was cleared every 2.3 years on median.
- None of the 10 ancestors has a recall.
- Of its descendants, K110497 (Medicrea International, 2011) has gone furthest, with 133 descendants of its own.
- 2 other devices also cite its predicate K982987.
How does its category compare?
All MNI devicesMNI Orthosis, Spinal Pedicle Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 PASS 2 Spinal System consists of pedicle screws, rods, nuts and clamps members utilized 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 thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis…
Read the full statement (129 words)
The PASS 2 Spinal System consists of pedicle screws, rods, nuts and clamps members utilized 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 thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis).
As a pedicle screw system, the PASS 2 Spinal System is intended for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebrae 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062136 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062136: Pass 2 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/K062136
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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