510(k) · Cleared

Recalled · Class II · 2019

Flamenco Spinal Fixation System

K102853510(k) TraditionalCleared Jan 25, 2011118-day reviewClass II21 CFR 888.3070Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Ulrich GmbH & Co. KG · MNH Orthosis, Spondylolisthesis Spinal Fixation

Cleared on Jan 25, 2011 as substantially equivalent to K031655 (Medtronic Sofamor Danek USA, Inc., 2003) and 9 other predicates after a 118-day review. Its family tree reaches back 5 generations to 1990. 22 later devices descend from it. It has been recalled once.

Decided: Jan 25, 2011
Review: 118 days
Class: Class II
Product code: MNH
Recalls: 1
Predicates: 10

Its longest line of descent runs back 5 generations to K901587 (1990). 33 ancestors in all. 22 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 5 generations backK901587 TSRH Sacral L-ConnectorDanek Medical, Inc. · 1990
4 generations backK950099 Synergy (TM) TI Posterior Spinal SystemBuckman Co., Inc. · 1997
3 generations backK973836 Synergy 6.35MM SS Rod with Screws for Anterior Use, Part of the…Cross Medical Products, Inc. · 1998
2 generations backK974749 Synergy Closed Variable Locking Screw (VLS), Part of the Cross…Cross Medical Products, Inc. · 1998
1 generation backK100377 Diamondback Spinal SystemEminent Spine · 2010
This deviceK102853 Flamenco Spinal Fixation SystemUlrich GmbH & Co. KG · 2011
Descendant · cites it directly · 18 of its ownK120891 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

Showing 5 of 22 descendants. See all descendants

Descendants cleared per year

2011high 4 (2024) · low 0 (2014)2026

Most influential descendants

Showing 5 of 22 · See all

K120891Tangors Multifunctional Posterior SystemUlrich GmbH & Co. KG · 2012 · cites it directly18descendants
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

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−5	K901587	TSRH Sacral L-Connector	Danek Medical, Inc.	1990	—
−4	K950099	Synergy (TM) TI Posterior Spinal System	Buckman Co., Inc.	1997	—
−3	K973836	Synergy 6.35MM SS Rod with Screws for Anterior Use, Part of the Cross…	Cross Medical Products, Inc.	1998	—
−2	K974749	Synergy Closed Variable Locking Screw (VLS), Part of the Cross Medical-Synergy…	Cross Medical Products, Inc.	1998	—
−1	K100377	Diamondback Spinal System	Eminent Spine	2010	—
0 (this device)	K102853	Flamenco Spinal Fixation System	Ulrich GmbH & Co. KG	2011	—
+1	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	—

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	1	0
2005	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2011	1	0
2012	1	0
2013	1	0
2015	2	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	2	0
2026	1	0

FIG. 1 — Lineage of K102853, 1990–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 MNH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

Get a 510(k) Report

What was it cleared against? (10)

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	Applicant	Decided	Recalls
*	K031655	CD Horizon Spinal System Summary page 2 …ents are manufactured from titanium alloy (Ti-6A1-4V) as described by ISO 5832-3 / ASTM Fl 36. Predicate Devices: CD HORIZON® (K031655/K041460) Moss Miami (K9921681K022623) Synergy VLS (K9500991K974749)…	Medtronic Sofamor Danek USA, Inc.	2003	1
*	K041460	CD Horizon Spinal System Summary page 2 …manufactured from titanium alloy (Ti-6A1-4V) as described by ISO 5832-3 / ASTM Fl 36. Predicate Devices: CD HORIZON® (K031655/K041460) Moss Miami (K9921681K022623) Synergy VLS (K9500991K974749)…	Medtronic Sofamor Danek USA, Inc.	2004	—
*	K992168	Moss Miami 6.35MM Polyaxial Screw Summary page 2 …(Ti-6A1-4V) as described by ISO 5832-3 / ASTM Fl 36. Predicate Devices: CD HORIZON® (K031655/K041460) Moss Miami (K9921681K022623) Synergy VLS (K9500991K974749) Optima TM (K024096/K031585/K0…	Depuyacromed	1999	—
*	K022623	5.0 MM Diameter Polyaxial Screws (Moss Miami 6.35MM System) Summary page 2 …(Ti-6A1-4V) as described by ISO 5832-3 / ASTM Fl 36. Predicate Devices: CD HORIZON® (K031655/K041460) Moss Miami (K9921681K022623) Synergy VLS (K9500991K974749) Optima TM (K024096/K031585/K051971)…	Depuyacromed	2002	—
*	K950099	Synergy (TM) TI Posterior Spinal System Summary page 2 …36. Predicate Devices: CD HORIZON® (K031655/K041460) Moss Miami (K9921681K022623) Synergy VLS (K9500991K974749) Optima TM (K024096/K031585/K051971) DiamondbackTM (Ki100377…	Buckman Co., Inc.	1997	—
*	K974749	Synergy Closed Variable Locking Screw (VLS), Part of the Cross Medical-Synergy Anterior… Summary page 2 …Predicate Devices: CD HORIZON® (K031655/K041460) Moss Miami (K9921681K022623) Synergy VLS (K9500991K974749) Optima TM (K024096/K031585/K051971) DiamondbackTM (Ki100377)…	Cross Medical Products, Inc.	1998	—
*	K024096	Optima, Spinal System Summary page 2 …041460) Moss Miami (K9921681K022623) Synergy VLS (K9500991K974749) Optima TM (K024096/K031585/K051971) DiamondbackTM (Ki100377) Technological The flamencom possesses th…	U&I Corp., America	2003	3
*	K031585	U&I, Optima, Spinal System Summary page 2 …Moss Miami (K9921681K022623) Synergy VLS (K9500991K974749) Optima TM (K024096/K031585/K051971) DiamondbackTM (Ki100377) Technological The flamencom possesses the same t…	U&I Corp., America	2003	5
*	K051971	Optima Spinal System Summary page 2 …Moss Miami (K9921681K022623) Synergy VLS (K9500991K974749) Optima TM (K024096/K031585/K051971) DiamondbackTM (Ki100377) Technological The flamencom possesses the same technolog…	U&I Corp.	2005	—
*	K100377	Diamondback Spinal System Summary page 2 …Synergy VLS (K9500991K974749) Optima TM (K024096/K031585/K051971) DiamondbackTM (Ki100377) Technological The flamencom possesses the same technological characteristics Characteristics: as t…	Eminent Spine	2010	—

Also cleared against K031655: 24 other devices →

What descends from it? (22)

See all 22

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K120891	Tangors Multifunctional Posterior System	Ulrich GmbH & Co. KG	2012	18
K123717	Ucentum	Ulrich GmbH & Co. KG	2013	17
K191932	Momentum™ Posterior Spinal Fixation System	Ulrich Medical USA	2019	2
K111883	Smartloc Spinal Fixation System	A-Spine Asia, Co., Ltd.	2011	2

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 21 years and passes through 5 companies; a new generation was cleared every 1.1 years on median.
4 of the 33 ancestors have a recall of any class.
Of its descendants, K120891 (Ulrich GmbH & Co. KG, 2012) has gone furthest, with 18 descendants of its own.
24 other devices also cite its predicate K031655.

How does its category compare?

All MNH devices

MNH Orthosis, Spondylolisthesis Spinal Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.

FDA decisions per year · MNH

8in 2016

2007high 17 (2011) · low 0 (2017)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MNH

93in 2016

2007high 171 (2011) · low 65 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MNH

1in 2016

2007high 7 (2009) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MNH

89in 2025

2007high 531 (2021) · low 18 (2007)2025

MAUDE reports naming product code MNH, 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	5	123	0	18
2008	13	65	0	30
2009	13	151	7	45
2010	10	106	0	59
2011	17	171	0	107
2012	7	93	1	433
2013	10	124	1	464
2014	12	140	0	286
2015	10	99	0	152
2016	8	93	1	216
2017	0	—	0	174
2018	0	—	0	129
2019	0	—	0	403
2020	0	—	0	432
2021	0	—	0	531
2022	0	—	0	265
2023	0	—	0	121
2024	0	—	0	302
2025	0	—	0	89
2026	0	—	0	—

What is it indicated for?

The flamencoTM is a spinal fixation system intended to provide immobilization and stabilization of thoracic, lumbar, and sacral spinal segments as an adjunct to fusion. When used as posterior, pedicle screw fixation, the system is intended for the treatment of severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients. In addition, when used as a pedicle screw fixation system in the non-cervical posterior spine (Ti to…

Read the full statement (170 words)

The flamencoTM is a spinal fixation system intended to provide immobilization and stabilization of thoracic, lumbar, and sacral spinal segments as an adjunct to fusion.

When used as posterior, pedicle screw fixation, the system is intended for the treatment of severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients. In addition, when used as a pedicle screw fixation system in the non-cervical posterior spine (Ti to 82), the system is intended for the treatment of the following acute and chronic instabilities or deformities: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, spinal stenosis, scoliosis, kyphosis, lordosis, spinal tumor, pseudarthrosis and failed previous fusion in skeletally mature patients.

When used as a posterior, non-cervical, hook and/or sacral/iliac fixation system (i.e., non-pedicle screw), the flamencoTM is intended for the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (as conformed by patient history and radiographic studies), spondylolisthesis, fracture, dislocation, scoliosis, kyphosis, lordlosis, spinal stenosis, spinal tumor, pseudarthrosis and failed previous fusion.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K102853 · printed Nov 5, 2026

Cite this page

510(k) Report. “K102853: Flamenco Spinal Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K102853

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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