510(k) · Cleared
ClearedTangors Multifunctional Posterior System
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 Oct 1, 2012 as substantially equivalent to K102853 (Ulrich GmbH & Co. KG, 2011) and 5 other predicates after a 192-day review. Its family tree reaches back 6 generations to 1990. 18 later devices descend from it.
- Decided
- Oct 1, 2012
- Review
- 192 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 6 generations to K901587 (1990). 38 ancestors in all. 18 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK901587 TSRH Sacral L-ConnectorDanek Medical, Inc. · 1990
- 5 generations backK950099 Synergy (TM) TI Posterior Spinal SystemBuckman Co., Inc. · 1997
- 4 generations backK973836 Synergy 6.35MM SS Rod with Screws for Anterior Use, Part of the…Cross Medical Products, Inc. · 1998
- 3 generations backK974749 Synergy Closed Variable Locking Screw (VLS), Part of the Cross…Cross Medical Products, Inc. · 1998
- 2 generations backK100377 Diamondback Spinal SystemEminent Spine · 2010
- 1 generation backK102853 Flamenco Spinal Fixation SystemUlrich GmbH & Co. KG · 2011 · Recalled
- This deviceK120891 Tangors Multifunctional Posterior SystemUlrich GmbH & Co. KG · 2012
- Descendant · cites it directly · 17 of its ownK123717 UcentumUlrich GmbH & Co. KG · 2013 · Recalled
- Descendant · 2 generations on · 11 of its ownK151727 Everest Spinal SystemK2m, Inc. · 2015
- Descendant · 3 generations on · 9 of its ownK161369 EVEREST Spinal SystemK2m, Incorporated · 2016
- Descendant · 4 generations on · 6 of its ownK181188 EVEREST Spinal SystemK2m, Inc. · 2018
- Descendant · 5 generations on · 5 of its ownK181603 EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System…K2m, Inc. · 2018
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K123717UcentumUlrich GmbH & Co. KG · 2013 · cites it directly17descendants
- K151727Everest Spinal SystemK2m, Inc. · 2015 · 2 generations on11descendants
- K161369EVEREST Spinal SystemK2m, Incorporated · 2016 · 3 generations on9descendants
- K181188EVEREST Spinal SystemK2m, Inc. · 2018 · 4 generations on6descendants
- K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc. · 2018 · 5 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K901587 | TSRH Sacral L-Connector | Danek Medical, Inc. | 1990 | — |
| −5 | K950099 | Synergy (TM) TI Posterior Spinal System | Buckman Co., Inc. | 1997 | — |
| −4 | K973836 | Synergy 6.35MM SS Rod with Screws for Anterior Use, Part of the Cross… | Cross Medical Products, Inc. | 1998 | — |
| −3 | K974749 | Synergy Closed Variable Locking Screw (VLS), Part of the Cross Medical-Synergy… | Cross Medical Products, Inc. | 1998 | — |
| −2 | K100377 | Diamondback Spinal System | Eminent Spine | 2010 | — |
| −1 | K102853 | Flamenco Spinal Fixation System | Ulrich GmbH & Co. KG | 2011 | 1 |
| 0 (this device) | K120891 | Tangors Multifunctional Posterior System | Ulrich GmbH & Co. KG | 2012 | — |
| +1 | K123717 | Ucentum | Ulrich GmbH & Co. KG | 2013 | 1 |
| +2 | K151727 | Everest Spinal System | K2m, Inc. | 2015 | — |
| +3 | K161369 | EVEREST Spinal System | K2m, Incorporated | 2016 | — |
| +4 | K181188 | EVEREST Spinal System | K2m, Inc. | 2018 | — |
| +5 | K181603 | EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT… | K2m, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1992 | 5 | 0 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 4 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 3 | 0 |
| 2004 | 3 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K102853 | Flamenco Spinal Fixation SystemSummary page 2…The tangoRS"m components are manufactured from titanium alloy (Ti-6A1-4V ELI) as described by ASTM F136. Predicate Devices: flamenco TM (K1 02853) CID HORIZON® (K031655/K041460) Expedium (K041 11 91K0621 96) tang… | 2011 |
| * | K031655 | CD Horizon Spinal SystemSummary page 2…ctured from titanium alloy (Ti-6A1-4V ELI) as described by ASTM F136. Predicate Devices: flamenco TM (K1 02853) CID HORIZON® (K031655/K041460) Expedium (K041 11 91K0621 96) tangoRS TM (K052385) Technological tangoR… | 2003 |
| * | K041460 | CD Horizon Spinal SystemSummary page 2…rom titanium alloy (Ti-6A1-4V ELI) as described by ASTM F136. Predicate Devices: flamenco TM (K1 02853) CID HORIZON® (K031655/K041460) Expedium (K041 11 91K0621 96) tangoRS TM (K052385) Technological tangoRS TM pos… | 2004 |
| * | K041119 | Expedium Spine System Our reading of the summary gave K041191, FDA’s number for Colleague Volumetric Infusion Pumps (Baxter Healthcare Corp). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “Expedium”. | 2004 |
| * | K062196 | SFX Snap-Fit Cross ConnectorSummary page 2…ELI) as described by ASTM F136. Predicate Devices: flamenco TM (K1 02853) CID HORIZON® (K031655/K041460) Expedium (K041 11 91K0621 96) tangoRS TM (K052385) Technological tangoRS TM possesses the same technological characteristics as on… | 2006 |
| * | K052385 | Tangors Polyaxial SystemSummary page 2…Devices: flamenco TM (K1 02853) CID HORIZON® (K031655/K041460) Expedium (K041 11 91K0621 96) tangoRS TM (K052385) Technological tangoRS TM possesses the same technological characteristics as one Characteristics: or more of the pred… | 2005 |
What descends from it? (18)
See all 181 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K123717 | Ucentum | 2013 | 17 |
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 22 years and passes through 5 companies; a new generation was cleared every 1.7 years on median.
- 5 of the 38 ancestors have a recall of any class.
- Of its descendants, K123717 (Ulrich GmbH & Co. KG, 2013) has gone furthest, with 17 descendants of its own.
- 3 other devices also cite its predicate K102853.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 tangoRS 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 tangoRS 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 lordosis), fracture, spinal tumor, pseudarthrosis and failed previous fusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120891 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120891: Tangors Multifunctional Posterior System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120891
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