510(k) · Cleared
ClearedPGS 5.5 MM Cannulated Pedicle Screw
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pinnacle Spine Group · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Dec 2, 2014 as substantially equivalent to K000236 (Interpore Cross Intl., 2000) and 8 other predicates after a 200-day review. Its family tree reaches back 11 generations to 1990. 1 later device descends from it.
- Decided
- Dec 2, 2014
- Review
- 200 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 9
Its longest line of descent runs back 11 generations to K901587 (1990). 85 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 11 generations backK901587 TSRH Sacral L-ConnectorDanek Medical, Inc. · 1990
- 7 generations between
- 3 generations backK062670 Vertiflex Spinal Screw SystemVertiflex (Tm), Incorporated · 2007
- 2 generations backK073245 Extended Vertiflex Spinal Screw SystemVertiflex, Inc. · 2008
- 1 generation backK102870 Exactech Proliant Polyaxial Pedicle Screw SystemExactech, Inc. · 2011
- This deviceK141282 PGS 5.5 MM Cannulated Pedicle ScrewPinnacle Spine Group · 2014
- Descendant · cites it directly · 0 of its ownK191655 MEGAFIX® Pedicle Screw Spinal SystemSeohancare Co., Ltd. · 2020
Show all 11 generations
- Root · 11 generations backK901587 TSRH Sacral L-ConnectorDanek Medical, Inc. · 1990
- 10 generations backK950099 Synergy (TM) TI Posterior Spinal SystemBuckman Co., Inc. · 1997
- 9 generations backK973836 Synergy 6.35MM SS Rod with Screws for Anterior Use, Part of the…Cross Medical Products, Inc. · 1998
- 8 generations backK974749 Synergy Closed Variable Locking Screw (VLS), Part of the Cross…Cross Medical Products, Inc. · 1998
- 7 generations backK993503 Haider-Ucr Spinal SystemInternational Advanced Medical Enterprises, Inc. · 2000
- 6 generations backK021623 Ucr Spinal System, 5.5MM, 8.0MM Screws & InstrumentsIame, Inc. · 2002
- 5 generations backK032739 Ucr Spinal SystemSeaspine · 2003
- 4 generations backK043232 Ucr Spinal SystemSeaspine · 2004 · Recalled
- 3 generations backK062670 Vertiflex Spinal Screw SystemVertiflex (Tm), Incorporated · 2007
- 2 generations backK073245 Extended Vertiflex Spinal Screw SystemVertiflex, Inc. · 2008
- 1 generation backK102870 Exactech Proliant Polyaxial Pedicle Screw SystemExactech, Inc. · 2011
- This deviceK141282 PGS 5.5 MM Cannulated Pedicle ScrewPinnacle Spine Group · 2014
Most influential descendants
Showing 1 of 1 · See all- K191655MEGAFIX® Pedicle Screw Spinal SystemSeohancare Co., Ltd. · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K901587 | TSRH Sacral L-Connector | Danek Medical, Inc. | 1990 | — |
| −10 | K950099 | Synergy (TM) TI Posterior Spinal System | Buckman Co., Inc. | 1997 | — |
| −9 | K973836 | Synergy 6.35MM SS Rod with Screws for Anterior Use, Part of the Cross… | Cross Medical Products, Inc. | 1998 | — |
| −8 | K974749 | Synergy Closed Variable Locking Screw (VLS), Part of the Cross Medical-Synergy… | Cross Medical Products, Inc. | 1998 | — |
| −7 | K993503 | Haider-Ucr Spinal System | International Advanced Medical Enterprises, Inc. | 2000 | — |
| −6 | K021623 | Ucr Spinal System, 5.5MM, 8.0MM Screws & Instruments | Iame, Inc. | 2002 | — |
| −5 | K032739 | Ucr Spinal System | Seaspine | 2003 | — |
| −4 | K043232 | Ucr Spinal System | Seaspine | 2004 | 1 |
| −3 | K062670 | Vertiflex Spinal Screw System | Vertiflex (Tm), Incorporated | 2007 | — |
| −2 | K073245 | Extended Vertiflex Spinal Screw System | Vertiflex, Inc. | 2008 | — |
| −1 | K102870 | Exactech Proliant Polyaxial Pedicle Screw System | Exactech, Inc. | 2011 | — |
| 0 (this device) | K141282 | PGS 5.5 MM Cannulated Pedicle Screw | Pinnacle Spine Group | 2014 | — |
| +1 | K191655 | MEGAFIX® Pedicle Screw Spinal System | Seohancare Co., Ltd. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1992 | 5 | 0 |
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 3 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 10 | 0 |
| 2001 | 3 | 0 |
| 2002 | 7 | 0 |
| 2003 | 9 | 0 |
| 2004 | 12 | 0 |
| 2005 | 8 | 0 |
| 2006 | 4 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 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? (9)
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 |
|---|---|---|---|
| * | K000236 | Synergy VLS Cap Nut Models 2206, 6102Summary page 6…on of spinal segments as an adjunct to fusion. Table 5-1 Predicate Devices 510k Number Trade or Proprietary or Model Name Manufacturer K000236 Synergy VLS Open Interpore K103490, K033901, K955348 Moss Miami Ti… | 2000 |
| * | K103490 | Expedium Spine System, Moss Miami Spine SystemSummary page 6…Trade or Proprietary or Model Name Manufacturer K000236 Synergy VLS Open Interpore K103490, K033901, K955348 Moss Miami Titanium DePuy Spine Inc. K081080 (Primary Predicate) TSRH… | 2011 |
| * | K033901 | Merlin Spine SystemSummary page 6…Trade or Proprietary or Model Name Manufacturer K000236 Synergy VLS Open Interpore K103490, K033901, K955348 Moss Miami Titanium DePuy Spine Inc. K081080 (Primary Predicate) TSRH… | 2004 |
| * | K955348 | Titanium Moss Miami Spinal SystemSummary page 6…Trade or Proprietary or Model Name Manufacturer K000236 Synergy VLS Open Interpore K103490, K033901, K955348 Moss Miami Titanium DePuy Spine Inc. K081080 (Primary Predicate) TSRH… | 1996 |
| * | K081080 | TSRH Spinal SystemSummary page 6…Synergy VLS Open Interpore K103490, K033901, K955348 Moss Miami Titanium DePuy Spine Inc. K081080 (Primary Predicate) TSRH Medtronic K020279, K051971, K024096 OPTIMA™… | 2008 |
| * | K020279 | Forex Corporation, Optima, Spinal SystemSummary page 6…K955348 Moss Miami Titanium DePuy Spine Inc. K081080 (Primary Predicate) TSRH Medtronic K020279, K051971, K024096 OPTIMA™ U&I Corporation K102870 Spine P… | 2002 |
| * | K051971 | Optima Spinal SystemSummary page 6…Moss Miami Titanium DePuy Spine Inc. K081080 (Primary Predicate) TSRH Medtronic K020279, K051971, K024096 OPTIMA™ U&I Corporation K102870 Spine Proliant S… | 2005 |
| * | K024096 | Optima, Spinal SystemSummary page 6…oss Miami Titanium DePuy Spine Inc. K081080 (Primary Predicate) TSRH Medtronic K020279, K051971, K024096 OPTIMA™ U&I Corporation K102870 Spine Proliant Screw Syst… | 2003 |
| * | K102870 | Exactech Proliant Polyaxial Pedicle Screw SystemSummary page 6…Predicate) TSRH Medtronic K020279, K051971, K024096 OPTIMA™ U&I Corporation K102870 Spine Proliant Screw System Exactech PERFORMANCE DATA The PSG 5.5mm Cannulated Pedic… | 2011 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K191655 | MEGAFIX® Pedicle Screw Spinal System | 2020 | 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 24 years and passes through 10 companies; a new generation was cleared every 2.1 years on median.
- 14 of the 85 ancestors have a recall of any class.
- Of its descendants, K191655 (Seohancare Co., Ltd., 2020) has gone furthest, with 0 descendants of its own.
- 11 other devices also cite its predicate K000236.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 PSG 5.5mm Cannulated Pedicle Screw System is intended to provide immobilization and stabilization of spinal segments 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 (i.e., fracture or…
Read the full statement (103 words)
The PSG 5.5mm Cannulated Pedicle Screw System is intended to provide immobilization and stabilization of spinal segments 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 (i.e., fracture or dislocation), deformity, or curvature (i.e., scoliosis, kyphosis, and lordosis), tumor, stenosis, pseudoarthrosis, and previous failed fusion.
The PSG 5.5mm Cannulated Pedicle Screw System is a non-cervical spinal fixation system. Pedicle screw fixation is limited to skeletally mature patients.
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/K141282 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141282: PGS 5.5 MM Cannulated Pedicle Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141282
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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