510(k) · Decided
DecidedPass LP Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medicrea International · OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis
Cleared on Feb 5, 2013 as substantially equivalent to K110497 (Medicrea International, 2011) and 1 other predicate after a 123-day review. Its family tree reaches back 8 generations to 2000. 132 later devices descend from it.
- Decided
- Feb 5, 2013
- Review
- 123 days
- Class
- Class II
- Product code
- OSH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K992147 (2000). 76 ancestors in all, the oldest K781443 (1978). 132 later devices descend from it, 6 citing it directly.
- Root · 8 generations backK992147 Triple-Fix Spinal Fixation SystemAdvanced Spine Technology, Inc. · 2000
- 7 generations backK001668 Global Spinal Fixation SystemD.K.M. Co., Ltd. · 2000
- 6 generations backK031455 Conklusion Pedicle Screw SystemSignus Medical, LLC · 2003
- 5 generations backK070933 Lowtop Pedicle Screw SystemSanacor · 2007
- 4 generations backK072187 Pioneer Lowtop Spinal Rod SystemPioneer Surgical Technology · 2007
- 3 generations backK080518 Pioneer Surgical Technology Quantum Spinal SystemPioneer Surgical Technology · 2008
- 2 generations backK100297 Pass LP Spinal SystemMedicrea Technologies · 2010
- 1 generation backK110497 Pass LP Spinal SystemMedicrea International · 2011 · Recalled
- This deviceK123138 Pass LP Spinal SystemMedicrea International · 2013
- Descendant · cites it directly · 84 of its ownK142798 PASS LP Spinal SystemMedicrea International SA · 2015
- Descendant · 2 generations on · 83 of its ownK152968 Arsenal Spinal Fixation SystemAlphatec Spine, Inc. · 2015
- Descendant · 3 generations on · 75 of its ownK161363 Arsenal Spinal Fixation SystemAlphatec Spine, Inc. · 2016
- Descendant · 3 generations on · 70 of its ownK181677 Kodiak Spinal Fixation SystemAlphatec Spine, Inc. · 2018
- Descendant · 3 generations on · 69 of its ownK192938 Invictus™ Spinal Fixation SystemAlphatec Spine, Inc. · 2019
Showing 5 of 132 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 132 · See all- K142798PASS LP Spinal SystemMedicrea International SA · 2015 · cites it directly84descendants
- K152968Arsenal Spinal Fixation SystemAlphatec Spine, Inc. · 2015 · 2 generations on83descendants
- K161363Arsenal Spinal Fixation SystemAlphatec Spine, Inc. · 2016 · 3 generations on75descendants
- K181677Kodiak Spinal Fixation SystemAlphatec Spine, Inc. · 2018 · 3 generations on70descendants
- K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc. · 2019 · 3 generations on69descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K992147 | Triple-Fix Spinal Fixation System | Advanced Spine Technology, Inc. | 2000 | — |
| −7 | K001668 | Global Spinal Fixation System | D.K.M. Co., Ltd. | 2000 | — |
| −6 | K031455 | Conklusion Pedicle Screw System | Signus Medical, LLC | 2003 | — |
| −5 | K070933 | Lowtop Pedicle Screw System | Sanacor | 2007 | — |
| −4 | K072187 | Pioneer Lowtop Spinal Rod System | Pioneer Surgical Technology | 2007 | — |
| −3 | K080518 | Pioneer Surgical Technology Quantum Spinal System | Pioneer Surgical Technology | 2008 | — |
| −2 | K100297 | Pass LP Spinal System | Medicrea Technologies | 2010 | — |
| −1 | K110497 | Pass LP Spinal System | Medicrea International | 2011 | 1 |
| 0 (this device) | K123138 | Pass LP Spinal System | Medicrea International | 2013 | — |
| +1 | K142798 | PASS LP Spinal System | Medicrea International SA | 2015 | — |
| +2 | K152968 | Arsenal Spinal Fixation System | Alphatec Spine, Inc. | 2015 | — |
| +3 | K161363 | Arsenal Spinal Fixation System | Alphatec Spine, Inc. | 2016 | — |
| +3 | K181677 | Kodiak Spinal Fixation System | Alphatec Spine, Inc. | 2018 | — |
| +3 | K192938 | Invictus™ Spinal Fixation System | Alphatec Spine, Inc. | 2019 | — |
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 |
|---|---|---|
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 4 | 0 |
| 2016 | 4 | 0 |
| 2017 | 7 | 0 |
| 2018 | 8 | 0 |
| 2019 | 2 | 0 |
| 2020 | 6 | 0 |
| 2021 | 5 | 0 |
| 2022 | 12 | 0 |
| 2023 | 14 | 0 |
| 2024 | 19 | 0 |
| 2025 | 24 | 0 |
| 2026 | 24 | 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 OSH? 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 |
|---|---|---|---|
| * | K110497 | Pass LP Spinal SystemSummary page 1…ation KWP Appliance, Fixation, Spinal Interlaminal 3. Predicate or legally marketed devices which are substantially equivalent: o The PASS LP Spinal System (MEDICREA, K110497) e The TSRH Spinal System (MEDTRONIC, K111842) 4. Description of the device: The PASS LP Spinal System is designed to contribut… | 2011 |
| * | K111942 | TSRH Spinal SystemsSummary page 2…ally equivalent to the ' MEDTRONIC TSRH Spine System, in terms of intended use, materials used, mechanical safety and performances. e The TSRH Spinal System (MEDTRONIC, K111942) K123138 The table below compares the features and characteristics of MEDlCREA@ INTERNATIONAL PASS LP Spinal Sy… | 2011 |
| † | K062136 | Pass 2 Spinal System | 2006 |
| † | K080099 | Pass Spinal System | 2008 |
| † | K082069 | Pass 2 Spinal System | 2008 |
| † | K082577 | Pass LP Spinal System | 2008 |
| † | K083308 | Pass LP Spinal System | 2008 |
| † | K083810 | Pass LP Spinal System | 2009 |
| † | K100297 | Pass LP Spinal System | 2010 |
| † | K112493 | Pass LP Spinal System | 2011 |
What descends from it? (132)
See all 1326 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 13 years and passes through 7 companies; a new generation was cleared every 1.6 years on median.
- 7 of the 76 ancestors have a recall of any class.
- Of its descendants, K142798 (Medicrea International SA, 2015) has gone furthest, with 84 descendants of its own.
How does its category compare?
All OSH devicesOSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · OSH
1in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · OSH
82in 2013
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OSH
1in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OSH
3in 2025
MAUDE reports naming product code OSH, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 3 | 76 | 0 | 1 |
| 2013 | 14 | 82 | 0 | 2 |
| 2014 | 1 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 3 |
| 2016 | 1 | — | 0 | 9 |
| 2017 | 0 | — | 1 | 4 |
| 2018 | 0 | — | 0 | 14 |
| 2019 | 0 | — | 0 | 12 |
| 2020 | 0 | — | 0 | 12 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 8 |
| 2023 | 0 | — | 0 | 18 |
| 2024 | 0 | — | 0 | 12 |
| 2025 | 0 | — | 0 | 3 |
| 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 (Pseudoarthrosis) * 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 (Pseudoarthrosis)
* 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 sacraliliac 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K123138 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123138: Pass LP 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/K123138
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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