510(k) · Decided
Recalled · Class II · 2019Ucentum
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ulrich GmbH & Co. KG · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Mar 4, 2013 as substantially equivalent to K052385 (Ulrich GmbH & Co. KG, 2005) and 5 other predicates after a 90-day review. Its family tree reaches back 8 generations to 1999. 17 later devices descend from it. It has been recalled once.
- Decided
- Mar 4, 2013
- Review
- 90 days
- Class
- Class II
- Product code
- NKB
- Recalls
- 1
- Predicates
- 6
Its longest line of descent runs back 8 generations to K990745 (1999). 58 ancestors in all, the oldest K901587 (1990). 17 later devices descend from it, 3 citing it directly.
- Root · 8 generations backK990745 Modification to Synthes Universal Spinal SystemSynthes Spine · 1999
- 7 generations backK992739 Click'xSynthes Spine · 2000 · Recalled
- 6 generations backK040442 Protex Stabilization SystemGlobus Medical, Inc. · 2004
- 5 generations backK052069 Protex Stabilization System with Additional ComponentesGlobus Medical, Inc. · 2005
- 4 generations backK061202 Revere Stabilization SystemGlobus Medical, Inc. · 2006
- 3 generations backK081195 Revere Uniplanar ScrewsGlobus Medical, Inc. · 2008
- 2 generations backK091782 Revere 6.35 Stabilization SystemGlobus Medical, Inc. · 2009
- 1 generation backK110280 Revlok Fenestrated Screw SystemGlobus Medical, Inc. · 2011
- This deviceK123717 UcentumUlrich GmbH & Co. KG · 2013
- Descendant · cites it directly · 11 of its ownK151727 Everest Spinal SystemK2m, Inc. · 2015
- Descendant · 2 generations on · 9 of its ownK161369 EVEREST Spinal SystemK2m, Incorporated · 2016
- Descendant · 3 generations on · 6 of its ownK181188 EVEREST Spinal SystemK2m, Inc. · 2018
- Descendant · 4 generations on · 5 of its ownK181603 EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System…K2m, Inc. · 2018
- Descendant · 5 generations on · 4 of its ownK222684 XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal…Stryker Spine · 2023
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K151727Everest Spinal SystemK2m, Inc. · 2015 · cites it directly11descendants
- K161369EVEREST Spinal SystemK2m, Incorporated · 2016 · 2 generations on9descendants
- K181188EVEREST Spinal SystemK2m, Inc. · 2018 · 3 generations on6descendants
- K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc. · 2018 · 4 generations on5descendants
- K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine · 2023 · 5 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K990745 | Modification to Synthes Universal Spinal System | Synthes Spine | 1999 | — |
| −7 | K992739 | Click'x | Synthes Spine | 2000 | 1 |
| −6 | K040442 | Protex Stabilization System | Globus Medical, Inc. | 2004 | — |
| −5 | K052069 | Protex Stabilization System with Additional Componentes | Globus Medical, Inc. | 2005 | — |
| −4 | K061202 | Revere Stabilization System | Globus Medical, Inc. | 2006 | — |
| −3 | K081195 | Revere Uniplanar Screws | Globus Medical, Inc. | 2008 | — |
| −2 | K091782 | Revere 6.35 Stabilization System | Globus Medical, Inc. | 2009 | — |
| −1 | K110280 | Revlok Fenestrated Screw System | Globus Medical, Inc. | 2011 | — |
| 0 (this device) | K123717 | Ucentum | Ulrich GmbH & Co. KG | 2013 | — |
| +1 | K151727 | Everest Spinal System | K2m, Inc. | 2015 | — |
| +2 | K161369 | EVEREST Spinal System | K2m, Incorporated | 2016 | — |
| +3 | K181188 | EVEREST Spinal System | K2m, Inc. | 2018 | — |
| +4 | K181603 | EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT… | K2m, Inc. | 2018 | — |
| +5 | K222684 | XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System… | Stryker Spine | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 2 | 0 |
| 1992 | 5 | 0 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 3 | 0 |
| 1998 | 3 | 0 |
| 1999 | 1 | 0 |
| 2000 | 5 | 0 |
| 2001 | 3 | 0 |
| 2002 | 2 | 0 |
| 2003 | 6 | 0 |
| 2004 | 4 | 0 |
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 4 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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? (6)
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 |
|---|---|---|---|
| * | K052385 | Tangors Polyaxial SystemSummary page 2…tem components are manufactured from titanium alloy (Ti-6A1-4V ELI) as described by ASTM F1 36. Predicate Devices: tangoRS TM (K052385 and K120891) flamenco TM (KI 02853) Moss Miami (K992168/K022623)… | 2005 |
| * | K120891 | Tangors Multifunctional Posterior SystemSummary page 2…ts are manufactured from titanium alloy (Ti-6A1-4V ELI) as described by ASTM F1 36. Predicate Devices: tangoRS TM (K052385 and K120891) flamenco TM (KI 02853) Moss Miami (K992168/K022623)… | 2012 |
| * | K102853 | Flamenco Spinal Fixation System | 2011 |
| * | K992168 | Moss Miami 6.35MM Polyaxial ScrewSummary page 2…M F1 36. Predicate Devices: tangoRS TM (K052385 and K120891) flamenco TM (KI 02853) Moss Miami (K992168/K022623) RevockTM Fenestrated Screw System (K1 10280) Performance Data: Mechanical te… | 1999 |
| * | K022623 | 5.0 MM Diameter Polyaxial Screws (Moss Miami 6.35MM System)Summary page 2…Predicate Devices: tangoRS TM (K052385 and K120891) flamenco TM (KI 02853) Moss Miami (K992168/K022623) RevockTM Fenestrated Screw System (K1 10280) Performance Data: Mechanical testing of… | 2002 |
| * | K110280 | Revlok Fenestrated Screw SystemSummary page 2…flamenco TM (KI 02853) Moss Miami (K992168/K022623) RevockTM Fenestrated Screw System (K1 10280) Performance Data: Mechanical testing of the worst case uCentumnTM constructs included… | 2011 |
What descends from it? (17)
See all 173 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 8, 2019 | Class II | Z-1126-2019 | Storage | Certain Torque Limiting Handles in the field are beyond their 3 year calibration life. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 14 years and passes through 3 companies; a new generation was cleared every 1.7 years on median.
- 8 of the 58 ancestors have a recall of any class.
- Of its descendants, K151727 (K2m, Inc., 2015) has gone furthest, with 11 descendants of its own.
- 2 other devices also cite its predicate K052385.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 uCentumTM comprehensive posterior system is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar and sacral spine (T1-S2). When used as a posterior spine thoracic/lumbar system, the uCentum is intended for the following indications: degenerative disc disease (as defined by back pain of discogenic with degeneration of the disc confirmed by patient history and radiographic studies), spinal stenosis, spondylolisthesis, spinal deformities (i.e., degenerative scoliosis, kyphosis, and/or lordlosis), fracture, spinal tumor, pseudarthrosis and failed previous fusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123717 · printed Nov 3, 2026
Cite this page
510(k) Report. “K123717: Ucentum.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K123717
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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