510(k) · Cleared
ClearedPass LP Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medicrea International · MNI Orthosis, Spinal Pedicle Fixation
Cleared on Nov 4, 2014 as substantially equivalent to K123138 (Medicrea International, 2013) after a 224-day review. Its family tree reaches back 9 generations to 2000. 47 later devices descend from it.
- Decided
- Nov 4, 2014
- Review
- 224 days
- Class
- Class II
- Product code
- MNI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K992147 (2000). 77 ancestors in all, the oldest K781443 (1978). 47 later devices descend from it, 9 citing it directly.
- Root · 9 generations backK992147 Triple-Fix Spinal Fixation SystemAdvanced Spine Technology, Inc. · 2000
- 5 generations between
- 3 generations backK100297 Pass LP Spinal SystemMedicrea Technologies · 2010
- 2 generations backK110497 Pass LP Spinal SystemMedicrea International · 2011 · Recalled
- 1 generation backK123138 Pass LP Spinal SystemMedicrea International · 2013
- This deviceK140738 Pass LP Spinal SystemMedicrea International · 2014
- Descendant · cites it directly · 21 of its ownK202771 CD Horizon Spinal SystemMedtronic · 2020
- Descendant · 2 generations on · 12 of its ownK211323 ASTRA Spine SystemSpinecraft, LLC · 2021
- Descendant · cites it directly · 11 of its ownK232275 Invictus® Spinal Fixation SystemAlphatec Spine, Inc. · 2023
- Descendant · 3 generations on · 8 of its ownK223273 ASTRA Spine SystemSpinecraft, LLC · 2022
- Descendant · cites it directly · 8 of its ownK211981 KHEIRON® Spinal Fixation SystemS.M.A.I.O · 2022
Show all 9 generations
- Root · 9 generations backK992147 Triple-Fix Spinal Fixation SystemAdvanced Spine Technology, Inc. · 2000
- 8 generations backK001668 Global Spinal Fixation SystemD.K.M. Co., Ltd. · 2000
- 7 generations backK031455 Conklusion Pedicle Screw SystemSignus Medical, LLC · 2003
- 6 generations backK070933 Lowtop Pedicle Screw SystemSanacor · 2007
- 5 generations backK072187 Pioneer Lowtop Spinal Rod SystemPioneer Surgical Technology · 2007
- 4 generations backK080518 Pioneer Surgical Technology Quantum Spinal SystemPioneer Surgical Technology · 2008
- 3 generations backK100297 Pass LP Spinal SystemMedicrea Technologies · 2010
- 2 generations backK110497 Pass LP Spinal SystemMedicrea International · 2011 · Recalled
- 1 generation backK123138 Pass LP Spinal SystemMedicrea International · 2013
- This deviceK140738 Pass LP Spinal SystemMedicrea International · 2014
Showing 5 of 47 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 47 · See all- K202771CD Horizon Spinal SystemMedtronic · 2020 · cites it directly21descendants
- K211323ASTRA Spine SystemSpinecraft, LLC · 2021 · 2 generations on12descendants
- K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc. · 2023 · cites it directly11descendants
- K223273ASTRA Spine SystemSpinecraft, LLC · 2022 · 3 generations on8descendants
- K211981KHEIRON® Spinal Fixation SystemS.M.A.I.O · 2022 · cites it directly8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K992147 | Triple-Fix Spinal Fixation System | Advanced Spine Technology, Inc. | 2000 | — |
| −8 | K001668 | Global Spinal Fixation System | D.K.M. Co., Ltd. | 2000 | — |
| −7 | K031455 | Conklusion Pedicle Screw System | Signus Medical, LLC | 2003 | — |
| −6 | K070933 | Lowtop Pedicle Screw System | Sanacor | 2007 | — |
| −5 | K072187 | Pioneer Lowtop Spinal Rod System | Pioneer Surgical Technology | 2007 | — |
| −4 | K080518 | Pioneer Surgical Technology Quantum Spinal System | Pioneer Surgical Technology | 2008 | — |
| −3 | K100297 | Pass LP Spinal System | Medicrea Technologies | 2010 | — |
| −2 | K110497 | Pass LP Spinal System | Medicrea International | 2011 | 1 |
| −1 | K123138 | Pass LP Spinal System | Medicrea International | 2013 | — |
| 0 (this device) | K140738 | Pass LP Spinal System | Medicrea International | 2014 | — |
| +1 | K202771 | CD Horizon Spinal System | Medtronic | 2020 | — |
| +2 | K211323 | ASTRA Spine System | Spinecraft, LLC | 2021 | — |
| +1 | K232275 | Invictus® Spinal Fixation System | Alphatec Spine, Inc. | 2023 | — |
| +3 | K223273 | ASTRA Spine System | Spinecraft, LLC | 2022 | — |
| +1 | K211981 | KHEIRON® Spinal Fixation System | S.M.A.I.O | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1998 | 3 | 0 |
| 1999 | 2 | 0 |
| 2000 | 10 | 0 |
| 2001 | 7 | 0 |
| 2002 | 6 | 0 |
| 2003 | 5 | 0 |
| 2004 | 8 | 0 |
| 2005 | 5 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 6 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 3 | 0 |
| 2022 | 5 | 0 |
| 2023 | 5 | 0 |
| 2024 | 7 | 0 |
| 2025 | 9 | 0 |
| 2026 | 15 | 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 |
|---|---|---|---|
| * | K123138 | Pass LP Spinal SystemSummary page 4…dolescent Idiopathic Scoliosis 3. Primary Predicate or legally marketed devices which are substantially equivalent: • PASS LP Spinal System, (MEDICREA INTERNATIONAL, K123138) 4. Description of the device: TheUNiD Rods have to be used with the PASS LP Spinal System designed to contribute to correctio… | 2013 |
What descends from it? (47)
See all 479 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K202771 | CD Horizon Spinal System | 2020 | 21 |
| K232275 | Invictus® Spinal Fixation System | 2023 | 11 |
| K211981 | KHEIRON® Spinal Fixation System | 2022 | 8 |
| K180376 | K2M Patient Specific Rods | 2018 | 2 |
| K253802 | KHEIRON® Spinal Fixation System, including patient specific K-ROD | 2026 | 1 |
| K220724 | CD Horizon™ Spinal System and PASS LP™ Spinal System | 2022 | 1 |
| K253739 | SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5… | 2026 | 0 |
| K213281 | PASS LP™ Spinal System, CD Horizon™ Spinal System | 2022 | 0 |
| K150049 | PASS LP Spinal 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 14 years and passes through 7 companies; a new generation was cleared every 1.6 years on median.
- 7 of the 77 ancestors have a recall of any class.
- Of its descendants, K202771 (Medtronic, 2020) has gone furthest, with 21 descendants of its own.
- 5 other devices also cite its predicate K123138.
How does its category compare?
All MNI devicesMNI Orthosis, Spinal Pedicle Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 PASS LP Spinal Systems include a pedicle 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 thoracic, lumbar, and sacral spine: - Fracture - Dislocation - Failed previous fusion (Pseudarthrosis) - Spinal stenosis - Degenerative spondylolisthesis with objective evidence of neurological…
Read the full statement (255 words)
The PASS LP Spinal Systems include a pedicle 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 thoracic, lumbar, and sacral spine:
- Fracture
- Dislocation
- Failed previous fusion (Pseudarthrosis)
- Spinal stenosis
- Degenerative spondylolisthesis with objective evidence of neurological impairment
- Spinal deformities such as scoliosis or kyphosis
- Loss of stability due to tumors
The PASS LP Spinal Systems are also indicated for pedicle screw fixation 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 fate the attainment of a solid fusion.
The PASS LP also includes hooks and rods and sacral/iliac screws 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.
Except for rod plates, when used for posterior non-cervical pedicle screw fixation in pediatric patients, the PASS LP Spinal System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The PASS LP Spinal System is intended to be used with allograft and/or autograft. Pediatric pedicle screw fixation is limited to a posterior approach.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140738 · printed Nov 5, 2026
Cite this page
510(k) Report. “K140738: Pass LP Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K140738
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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