510(k) · Cleared
ClearedPrase MIS Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gbs Commonwealth Co., Ltd. · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Oct 4, 2018 as substantially equivalent to K161766 (L&K BIOMED Co., Ltd., 2016) and 1 other predicate after a 65-day review. Its family tree reaches back 12 generations to 1999. 2 later devices descend from it.
- Decided
- Oct 4, 2018
- Review
- 65 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 12 generations to K990745 (1999). 133 ancestors in all, the oldest K933881 (1994). 2 later devices descend from it, 1 citing it directly.
- Root · 12 generations backK990745 Modification to Synthes Universal Spinal SystemSynthes Spine · 1999
- 8 generations between
- 3 generations backK102488 Apex Spine System W/ Cocr RodsSpinecraft, LLC · 2010
- 2 generations backK120270 Venus Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2012
- 1 generation backK173645 JASPER Spinal Fixation SystemGbs Commonwealth Co., Ltd. · 2018
- This deviceK182059 Prase MIS Spinal SystemGbs Commonwealth Co., Ltd. · 2018
- Descendant · cites it directly · 1 of its ownK190762 The JASPER Spinal Fixation System IIGbs Commonwealth Co., Ltd. · 2019
- Descendant · 2 generations on · 0 of its ownK232292 Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd. · 2023
Show all 12 generations
- Root · 12 generations backK990745 Modification to Synthes Universal Spinal SystemSynthes Spine · 1999
- 11 generations backK992739 Click'xSynthes Spine · 2000 · Recalled
- 10 generations backK040442 Protex Stabilization SystemGlobus Medical, Inc. · 2004
- 9 generations backK052069 Protex Stabilization System with Additional ComponentesGlobus Medical, Inc. · 2005
- 8 generations backK061202 Revere Stabilization SystemGlobus Medical, Inc. · 2006
- 7 generations backK081195 Revere Uniplanar ScrewsGlobus Medical, Inc. · 2008
- 6 generations backK091782 Revere 6.35 Stabilization SystemGlobus Medical, Inc. · 2009
- 5 generations backK093294 Revere Stabilization SystemGlobus Medical, Inc. · 2010
- 4 generations backK100788 Cocr RodsGlobus Medical, Inc. · 2010
- 3 generations backK102488 Apex Spine System W/ Cocr RodsSpinecraft, LLC · 2010
- 2 generations backK120270 Venus Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2012
- 1 generation backK173645 JASPER Spinal Fixation SystemGbs Commonwealth Co., Ltd. · 2018
- This deviceK182059 Prase MIS Spinal SystemGbs Commonwealth Co., Ltd. · 2018
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K990745 | Modification to Synthes Universal Spinal System | Synthes Spine | 1999 | — |
| −11 | K992739 | Click'x | Synthes Spine | 2000 | 1 |
| −10 | K040442 | Protex Stabilization System | Globus Medical, Inc. | 2004 | — |
| −9 | K052069 | Protex Stabilization System with Additional Componentes | Globus Medical, Inc. | 2005 | — |
| −8 | K061202 | Revere Stabilization System | Globus Medical, Inc. | 2006 | — |
| −7 | K081195 | Revere Uniplanar Screws | Globus Medical, Inc. | 2008 | — |
| −6 | K091782 | Revere 6.35 Stabilization System | Globus Medical, Inc. | 2009 | — |
| −5 | K093294 | Revere Stabilization System | Globus Medical, Inc. | 2010 | — |
| −4 | K100788 | Cocr Rods | Globus Medical, Inc. | 2010 | — |
| −3 | K102488 | Apex Spine System W/ Cocr Rods | Spinecraft, LLC | 2010 | — |
| −2 | K120270 | Venus Spinal Fixation System | L&K BIOMED Co., Ltd. | 2012 | — |
| −1 | K173645 | JASPER Spinal Fixation System | Gbs Commonwealth Co., Ltd. | 2018 | — |
| 0 (this device) | K182059 | Prase MIS Spinal System | Gbs Commonwealth Co., Ltd. | 2018 | — |
| +1 | K190762 | The JASPER Spinal Fixation System II | Gbs Commonwealth Co., Ltd. | 2019 | — |
| +2 | K232292 | Peridot-EX Expandable Intervertebral Body Fusion System | Gbs Commonwealth Co., Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 3 | 0 |
| 1996 | 2 | 0 |
| 1997 | 3 | 0 |
| 1998 | 6 | 0 |
| 1999 | 4 | 0 |
| 2000 | 14 | 0 |
| 2001 | 10 | 0 |
| 2002 | 5 | 0 |
| 2003 | 10 | 0 |
| 2004 | 10 | 0 |
| 2005 | 13 | 0 |
| 2006 | 11 | 0 |
| 2007 | 6 | 0 |
| 2008 | 9 | 0 |
| 2009 | 6 | 0 |
| 2010 | 3 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2016 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2023 | 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? (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 |
|---|---|---|---|
| * | K161766 | PathLoc-L MIS Spinal SystemSummary page 4…nitial product Introduction of Prase MIS Spinal System 3. Predicate or legally marketed devices which are substantially equivalent 1) Primary Predicate Device: K161766 Pathloc-L MIS Spinal System 2) Additional Predicate Device: K173645 JASPER Spinal Fixation System 4. Description of t… | 2016 |
| * | K173645 | JASPER Spinal Fixation SystemSummary page 4…legally marketed devices which are substantially equivalent 1) Primary Predicate Device: K161766 Pathloc-L MIS Spinal System 2) Additional Predicate Device: K173645 JASPER Spinal Fixation System 4. Description of the Device Prase MIS Spinal System consists of cannulated poly screws… | 2018 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K190762 | The JASPER Spinal Fixation System II | 2019 | 1 |
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 19 years and passes through 5 companies; a new generation was cleared every 1.2 years on median.
- 13 of the 133 ancestors have a recall of any class.
- Of its descendants, K190762 (Gbs Commonwealth Co., Ltd., 2019) has gone furthest, with 1 descendant of its own.
- 4 other devices also cite its predicate K161766.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 Prase MIS Spinal System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine. And the Prase MIS Spinal System can be used in an open approach and a percutaneous approach. The Prase MIS Spinal System is intended for the following indications: • Degenerative disc disease…
Read the full statement (122 words)
The Prase MIS Spinal System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine. And the Prase MIS Spinal System can be used in an open approach and a percutaneous approach. The Prase MIS Spinal System is intended for the following indications:
• Degenerative disc disease (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
• Curvatures (i.e., scoliosis, kyphosis, and for lordosis)
• Tumor
• Pseudarthrosis
• Failed previous fusion in skeletally mature patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K182059 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182059: Prase MIS 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/K182059
Report an extraction error
Are you the manufacturer?
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