510(k) · Cleared
ClearedPassmed Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medicrea · KWP Appliance, Fixation, Spinal Interlaminal
Cleared on Nov 14, 2003 as substantially equivalent to K001024 (Encore Orthopedics, Inc., 2000) and 5 other predicates after a 130-day review. Its family tree reaches back 2 generations to 2000. 149 later devices descend from it.
- Decided
- Nov 14, 2003
- Review
- 130 days
- Class
- Class II
- Product code
- KWP
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 2 generations to K001024 (2000). 6 ancestors in all. 149 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK001024 Pass Spinal SystemEncore Orthopedics, Inc. · 2000
- 1 generation backK012175 Pass Spinal SystemEncore Orthopedics, Inc. · 2001
- This deviceK032094 Passmed Spinal SystemMedicrea · 2003
- Descendant · cites it directly · 146 of its ownK062136 Pass 2 Spinal SystemMedicrea · 2006
- Descendant · 2 generations on · 133 of its ownK110497 Pass LP Spinal SystemMedicrea International · 2011 · Recalled
- Descendant · 3 generations on · 132 of its ownK123138 Pass LP Spinal SystemMedicrea International · 2013
- Descendant · 4 generations on · 84 of its ownK142798 PASS LP Spinal SystemMedicrea International SA · 2015
- Descendant · 5 generations on · 83 of its ownK152968 Arsenal Spinal Fixation SystemAlphatec Spine, Inc. · 2015
Showing 5 of 149 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 149 · See all- K062136Pass 2 Spinal SystemMedicrea · 2006 · cites it directly146descendants
- K110497Pass LP Spinal SystemMedicrea International · 2011 · 2 generations on133descendants
- K123138Pass LP Spinal SystemMedicrea International · 2013 · 3 generations on132descendants
- K142798PASS LP Spinal SystemMedicrea International SA · 2015 · 4 generations on84descendants
- K152968Arsenal Spinal Fixation SystemAlphatec Spine, Inc. · 2015 · 5 generations on83descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K001024 | Pass Spinal System | Encore Orthopedics, Inc. | 2000 | — |
| −1 | K012175 | Pass Spinal System | Encore Orthopedics, Inc. | 2001 | — |
| 0 (this device) | K032094 | Passmed Spinal System | Medicrea | 2003 | — |
| +1 | K062136 | Pass 2 Spinal System | Medicrea | 2006 | — |
| +2 | K110497 | Pass LP Spinal System | Medicrea International | 2011 | 1 |
| +3 | K123138 | Pass LP Spinal System | Medicrea International | 2013 | — |
| +4 | K142798 | PASS LP Spinal System | Medicrea International SA | 2015 | — |
| +5 | K152968 | Arsenal Spinal Fixation System | Alphatec Spine, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 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 KWP? 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? (6)
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 |
|---|---|---|---|
| * | K001024 | Pass Spinal SystemSummary page 1…888.3070 Spinal Interlaminal Fixation Orthosis per KWYP 888.3050 Equivalent Device The components covered by this submission are exactly the same as those cleared in K001024, K012175, K013191, K013431, K013442 and K020236. Thesc devices were all submitted by Encore Orthopedics. All of the cleared devic… | 2000 |
| * | K012175 | Pass Spinal SystemSummary page 1…Spinal Interlaminal Fixation Orthosis per KWYP 888.3050 Equivalent Device The components covered by this submission are exactly the same as those cleared in K001024, K012175, K013191, K013431, K013442 and K020236. Thesc devices were all submitted by Encore Orthopedics. All of the cleared devices were d… | 2001 |
| * | K013191 | Pass Spinal SystemSummary page 1…Interlaminal Fixation Orthosis per KWYP 888.3050 Equivalent Device The components covered by this submission are exactly the same as those cleared in K001024, K012175, K013191, K013431, K013442 and K020236. Thesc devices were all submitted by Encore Orthopedics. All of the cleared devices were designed,… | 2001 |
| * | K013431 | Pass Spinal SystemSummary page 1…nal Fixation Orthosis per KWYP 888.3050 Equivalent Device The components covered by this submission are exactly the same as those cleared in K001024, K012175, K013191, K013431, K013442 and K020236. Thesc devices were all submitted by Encore Orthopedics. All of the cleared devices were designed, manufactu… | 2001 |
| * | K013442 | Pass Spinal SystemSummary page 1…ion Orthosis per KWYP 888.3050 Equivalent Device The components covered by this submission are exactly the same as those cleared in K001024, K012175, K013191, K013431, K013442 and K020236. Thesc devices were all submitted by Encore Orthopedics. All of the cleared devices were designed, manufactured and p… | 2002 |
| * | K020236 | Modification to Pass Spinal SystemSummary page 1…per KWYP 888.3050 Equivalent Device The components covered by this submission are exactly the same as those cleared in K001024, K012175, K013191, K013431, K013442 and K020236. Thesc devices were all submitted by Encore Orthopedics. All of the cleared devices were designed, manufactured and packaged by M… | 2002 |
What descends from it? (149)
See all 1493 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 3 years and passes through 2 companies; a new generation was cleared every 2.3 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K062136 (Medicrea, 2006) has gone furthest, with 146 descendants of its own.
- 5 other devices also cite its predicate K001024.
How does its category compare?
All KWP devicesKWP Appliance, Fixation, Spinal Interlaminal: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KWP
9in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · KWP
113in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWP
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWP
494in 2025
MAUDE reports naming product code KWP, 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 | 14 | 96 | 2 | 210 |
| 2008 | 13 | 50 | 1 | 594 |
| 2009 | 12 | 89 | 23 | 682 |
| 2010 | 14 | 186 | 2 | 474 |
| 2011 | 12 | 67 | 6 | 792 |
| 2012 | 18 | 112 | 1 | 918 |
| 2013 | 12 | 99 | 3 | 1,090 |
| 2014 | 13 | 138 | 0 | 1,022 |
| 2015 | 9 | 113 | 1 | 1,348 |
| 2016 | 0 | — | 3 | 1,379 |
| 2017 | 0 | — | 0 | 864 |
| 2018 | 0 | — | 1 | 657 |
| 2019 | 0 | — | 2 | 518 |
| 2020 | 0 | — | 0 | 796 |
| 2021 | 0 | — | 0 | 525 |
| 2022 | 0 | — | 2 | 335 |
| 2023 | 0 | — | 0 | 332 |
| 2024 | 0 | — | 0 | 436 |
| 2025 | 0 | — | 0 | 494 |
| 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 hsion…
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 hsion (pseudarthrosis).
As a pedicle screw system PASSmed is indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-Sl 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 (Le., fracture or dislocation), spinal stenosis, deformities or curvatures (Le., scoliosis, kyphosis, andor lordosis), tumor, pseudoarthrosis and failed previous fusion.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K032094 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032094: 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/K032094
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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