510(k) · Cleared
ClearedModification to Passmed Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medicrea Technologies · MNH Orthosis, Spondylolisthesis Spinal Fixation
Cleared on Oct 18, 2007 as substantially equivalent to K032094 (Medicrea, 2003) and 2 other predicates after a 237-day review. Its family tree reaches back 3 generations to 2000. 2 later devices descend from it.
- Decided
- Oct 18, 2007
- Review
- 237 days
- Class
- Class II
- Product code
- MNH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K001024 (2000). 16 ancestors in all, the oldest K964159 (1997). 2 later devices descend from it, 1 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 deviceK070530 Modification to Passmed Spinal SystemMedicrea Technologies · 2007
- Descendant · cites it directly · 1 of its ownK190376 PASS LP Spinal SystemMedicrea International SA · 2019 · Recalled
- Descendant · 2 generations on · 0 of its ownK213281 PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA · 2022
Most influential descendants
Showing 2 of 2 · See allView 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) | K070530 | Modification to Passmed Spinal System | Medicrea Technologies | 2007 | — |
| +1 | K190376 | PASS LP Spinal System | Medicrea International SA | 2019 | 5 |
| +2 | K213281 | PASS LP™ Spinal System, CD Horizon™ Spinal System | Medicrea International SA | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2001 | 4 | 0 |
| 2002 | 4 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2022 | 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? (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 |
|---|---|---|---|
| * | K032094 | Passmed Spinal SystemSummary page 1…KWP CFR section 888.3070 / 888.3050 Device panel Orthopedic Legally marketed predicate [Medicrea PASSMed Spinal System: K032094 devices [Mectronic CD Horizon®: K014296 [EBI® Array Tm Spinal Fixati… | 2003 |
| * | K014296 | CD Horizon Spinal SystemSummary page 1…anel Orthopedic Legally marketed predicate [Medicrea PASSMed Spinal System: K032094 devices [Mectronic CD Horizon®: K014296 [EBI® Array Tm Spinal Fixation System: K042772 Reason for special 51 0(k) Product rang… | 2002 |
| * | K042772 | Ebi Array Spinal Fixation System and Spinelink II Spinal Fixation DeviceSummary page 1…ASSMed Spinal System: K032094 devices [Mectronic CD Horizon®: K014296 [EBI® Array Tm Spinal Fixation System: K042772 Reason for special 51 0(k) Product range extension and additional components Submitter [MEDICREA®… | 2004 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K190376 | PASS LP Spinal System | 2019 | 1 |
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 7 years and passes through 3 companies; a new generation was cleared every 2.3 years on median.
- None of the 16 ancestors has a recall.
- Of its descendants, K190376 (Medicrea International SA, 2019) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K032094.
How does its category compare?
All MNH devicesMNH Orthosis, Spondylolisthesis Spinal Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 PASSmed is a pedicle screw system 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…
Read the full statement (173 words)
The PASSmed is a pedicle screw system 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 (pseudoarthrosis).
As a pedicle screw system PASSmed is indicated for the treatment of severe spondylolisthesis (Grades 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.
It also includes hooks and a sacral plate indicated for degenerative disc disease (ddd) defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis and failed previous fusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070530 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070530: Modification to Passmed 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/K070530
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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