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 Feb 10, 2015 as substantially equivalent to K140738 (Medicrea International, 2014) and 1 other predicate after a 29-day review. Its family tree reaches back 10 generations to 2000.
- Decided
- Feb 10, 2015
- Review
- 29 days
- Class
- Class II
- Product code
- MNI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K992147 (2000). 78 ancestors in all, the oldest K781443 (1978). No later device cites it as a predicate yet.
- Root · 10 generations backK992147 Triple-Fix Spinal Fixation SystemAdvanced Spine Technology, Inc. · 2000
- 6 generations between
- 3 generations backK110497 Pass LP Spinal SystemMedicrea International · 2011 · Recalled
- 2 generations backK123138 Pass LP Spinal SystemMedicrea International · 2013
- 1 generation backK140738 Pass LP Spinal SystemMedicrea International · 2014
- This deviceK150049 PASS LP Spinal SystemMedicrea International · 2015
Show all 10 generations
- Root · 10 generations backK992147 Triple-Fix Spinal Fixation SystemAdvanced Spine Technology, Inc. · 2000
- 9 generations backK001668 Global Spinal Fixation SystemD.K.M. Co., Ltd. · 2000
- 8 generations backK031455 Conklusion Pedicle Screw SystemSignus Medical, LLC · 2003
- 7 generations backK070933 Lowtop Pedicle Screw SystemSanacor · 2007
- 6 generations backK072187 Pioneer Lowtop Spinal Rod SystemPioneer Surgical Technology · 2007
- 5 generations backK080518 Pioneer Surgical Technology Quantum Spinal SystemPioneer Surgical Technology · 2008
- 4 generations backK100297 Pass LP Spinal SystemMedicrea Technologies · 2010
- 3 generations backK110497 Pass LP Spinal SystemMedicrea International · 2011 · Recalled
- 2 generations backK123138 Pass LP Spinal SystemMedicrea International · 2013
- 1 generation backK140738 Pass LP Spinal SystemMedicrea International · 2014
- This deviceK150049 PASS LP Spinal SystemMedicrea International · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K992147 | Triple-Fix Spinal Fixation System | Advanced Spine Technology, Inc. | 2000 | — |
| −9 | K001668 | Global Spinal Fixation System | D.K.M. Co., Ltd. | 2000 | — |
| −8 | K031455 | Conklusion Pedicle Screw System | Signus Medical, LLC | 2003 | — |
| −7 | K070933 | Lowtop Pedicle Screw System | Sanacor | 2007 | — |
| −6 | K072187 | Pioneer Lowtop Spinal Rod System | Pioneer Surgical Technology | 2007 | — |
| −5 | K080518 | Pioneer Surgical Technology Quantum Spinal System | Pioneer Surgical Technology | 2008 | — |
| −4 | K100297 | Pass LP Spinal System | Medicrea Technologies | 2010 | — |
| −3 | K110497 | Pass LP Spinal System | Medicrea International | 2011 | 1 |
| −2 | K123138 | Pass LP Spinal System | Medicrea International | 2013 | — |
| −1 | K140738 | Pass LP Spinal System | Medicrea International | 2014 | — |
| 0 (this device) | K150049 | PASS LP Spinal System | Medicrea International | 2015 | — |
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 |
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? (2)
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 |
|---|---|---|---|
| * | K140738 | Pass LP Spinal SystemSummary page 5…K150049: Page 2 of 3 3. PREDICATE DEVICE The primary predicate of this submission is x PASS LP Patient Specific Rods(MEDICREA INTERNATIONAL, K140738) An additional predicate for this submission is x PASS LP Spinal System (MEDICREA INTERNATIONAL, K123138) These predicates… | 2014 |
| * | K123138 | Pass LP Spinal SystemSummary page 5…x PASS LP Patient Specific Rods(MEDICREA INTERNATIONAL, K140738) An additional predicate for this submission is x PASS LP Spinal System (MEDICREA INTERNATIONAL, K123138) These predicates have not been subject to a design-related recall. No reference device was used in this submission. 4.… | 2013 |
What descends from it?
No later submission names this one as a predicate yet.
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 15 years and passes through 7 companies; a new generation was cleared every 1.6 years on median.
- 7 of the 78 ancestors have a recall of any class.
- 8 other devices also cite its predicate K140738.
How does its category compare?
All MNI devicesMNI Orthosis, Spinal Pedicle Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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: • Fractures • 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:
• Fractures
• Dislocation
• Failed previous fusion (Pseudarthrosis)
• Spinal Stenosis
• Degenerative spondylolisthesis with objective evidence of neurological impairment
• Spinal deformations 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 after the attainment of a solid fusion.
The PASS LP also include 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, Pseudarthrosis 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/K150049 · printed Nov 4, 2026
Cite this page
510(k) Report. “K150049: PASS LP Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K150049
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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