510(k) · Cleared
ClearedPASS XS Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medicrea International SA · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Sep 23, 2016 as substantially equivalent to K141398 (Medicrea International SA, 2015) after a 200-day review. Its family tree reaches back 10 generations to 2000.
- Decided
- Sep 23, 2016
- Review
- 200 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K992147 (2000). 87 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 backK141398 Pass LP Spinal SystemMedicrea International SA · 2015 · Recalled
- This deviceK160640 PASS XS Spinal SystemMedicrea International SA · 2016
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 backK141398 Pass LP Spinal SystemMedicrea International SA · 2015 · Recalled
- This deviceK160640 PASS XS Spinal SystemMedicrea International SA · 2016
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 | K141398 | Pass LP Spinal System | Medicrea International SA | 2015 | 1 |
| 0 (this device) | K160640 | PASS XS Spinal System | Medicrea International SA | 2016 | — |
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 | 11 | 0 |
| 2005 | 8 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 6 | 0 |
| 2009 | 3 | 0 |
| 2010 | 3 | 0 |
| 2011 | 2 | 0 |
| 2014 | 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 NKB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new NKB device
- #1 K223494 CD Horizon Spinal Systemscore 40.4 · 30 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K141398 | Pass LP Spinal SystemSummary page 4…fication Name: WĞĚŝĐůĞ^ĐƌĞǁ^ƉŝŶĂů^LJƐƚĞŵ;Ϯϭ&Zϴϴϴ͘ϯϬϳϬͿ Regulatory Class: III Product Code: NKB, OSH, MNI, MNH PREDICATE DEVICES Medicrea Pass LP Spinal System, K141398 (primary). Synthes Spine USS Small Stature Spinal System, K994121 (additional). Globus Medical Revere 4.5 Spinal Stabilization Sy… | 2015 |
| † | K994121 | Small Stature Uss | 2000 |
| † | K113395 | Revere 4.5 Stabilization System | 2012 |
| † | K964024 | Depuy Motech Titanium Moss Miami Spinal System | 1997 |
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 16 years and passes through 8 companies; a new generation was cleared every 1.7 years on median.
- 10 of the 87 ancestors have a recall of any class.
- 3 other devices also cite its predicate K141398.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · NKB
24in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NKB
61in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NKB
1in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · NKB
1,171in 2025
MAUDE reports naming product code NKB, 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 | 38 | 87 | 4 | 34 |
| 2008 | 36 | 59 | 5 | 82 |
| 2009 | 44 | 71 | 33 | 171 |
| 2010 | 37 | 111 | 4 | 462 |
| 2011 | 48 | 84 | 3 | 577 |
| 2012 | 60 | 79 | 13 | 1,747 |
| 2013 | 35 | 73 | 0 | 1,962 |
| 2014 | 46 | 90 | 3 (1) | 1,671 |
| 2015 | 55 | 90 | 3 | 1,446 |
| 2016 | 50 | 84 | 1 | 1,585 |
| 2017 | 63 | 69 | 1 | 1,618 |
| 2018 | 56 | 61 | 3 | 1,684 |
| 2019 | 39 | 84 | 1 | 1,915 |
| 2020 | 48 | 68 | 1 | 2,076 |
| 2021 | 32 | 61 | 0 | 1,745 |
| 2022 | 34 | 88 | 5 | 1,339 |
| 2023 | 44 | 72 | 2 | 919 |
| 2024 | 39 | 57 | 3 | 1,614 |
| 2025 | 24 | 61 | 1 | 1,171 |
| 2026 | 30 | 91 | 3 | — |
What is it indicated for?
The PASS XS Spinal System is a pedicle screw fixation system intended for 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 disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies)…
Read the full statement (141 words)
The PASS XS Spinal System is a pedicle screw fixation system intended for 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 disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (e.g., fracture or dislocation), deformity or curvature (e.g., scoliosis, kyphosis, and/or lordosis), tumor, spinal stenosis, pseudoarthrosis, or failed previous fusion.
When used for posterior non-cervical pedicle screw fixation in pediatric patients, the PASS XS Spinal System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The PASS XS Spinal System is intended to be used with autograft and/or allograft. 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/K160640 · printed Nov 4, 2026
Cite this page
510(k) Report. “K160640: PASS XS 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/K160640
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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