510(k) · Cleared

Cleared

Synergy (TM) TI Posterior Spinal System

K950099510(k) TraditionalCleared Jan 16, 1997737-day reviewClass II21 CFR 888.3070

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

Buckman Co., Inc. · MNH Orthosis, Spondylolisthesis Spinal Fixation

Cleared on Jan 16, 1997 as substantially equivalent to K901005 (Danek Medical, Inc., 1990) and 8 other predicates after a 737-day review. Its family tree reaches back 1 generation to 1990. 579 later devices descend from it.

Decided: Jan 16, 1997
Review: 737 days
Class: Class II
Product code: MNH
Recalls: None
Predicates: 13

Its longest line of descent runs back 1 generation to K901587 (1990). 9 ancestors in all. 579 later devices descend from it, 35 citing it directly.

By dateBy generation

Root · 1 generation backK901587 TSRH Sacral L-ConnectorDanek Medical, Inc. · 1990
This deviceK950099 Synergy (TM) TI Posterior Spinal SystemBuckman Co., Inc. · 1997
Descendant · cites it directly · 529 of its ownK973836 Synergy 6.35MM SS Rod with Screws for Anterior Use, Part of the…Cross Medical Products, Inc. · 1998
Descendant · cites it directly · 311 of its ownK974749 Synergy Closed Variable Locking Screw (VLS), Part of the Cross…Cross Medical Products, Inc. · 1998
Descendant · cites it directly · 251 of its ownK982914 Aesculap Spine System Evolution: Additional ComponentsAesculap, Inc. · 1998
Descendant · cites it directly · 251 of its ownK980484 Aesculap Spine System EvolutionAesculap, Inc. · 1998
Descendant · cites it directly · 250 of its ownK990118 Isobar Spinal SystemScien'Tx USA, Inc. · 1999

Showing 5 of 579 descendants. See all descendants

Descendants cleared per year

1998high 49 (2023) · low 1 (2001)2026

Most influential descendants

Showing 5 of 579 · See all

K973836Synergy 6.35MM SS Rod with Screws for Anterior Use, Part of the Cross Medical-Synergy…Cross Medical Products, Inc. · 1998 · cites it directly529descendants
K974749Synergy Closed Variable Locking Screw (VLS), Part of the Cross Medical-Synergy Anterior…Cross Medical Products, Inc. · 1998 · cites it directly311descendants
K982914Aesculap Spine System Evolution: Additional ComponentsAesculap, Inc. · 1998 · cites it directly251descendants
K980484Aesculap Spine System EvolutionAesculap, Inc. · 1998 · cites it directly251descendants
K990118Isobar Spinal SystemScien'Tx USA, Inc. · 1999 · cites it directly250descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K901587	TSRH Sacral L-Connector	Danek Medical, Inc.	1990	—
0 (this device)	K950099	Synergy (TM) TI Posterior Spinal System	Buckman Co., Inc.	1997	—
+1	K973836	Synergy 6.35MM SS Rod with Screws for Anterior Use, Part of the Cross…	Cross Medical Products, Inc.	1998	—
+1	K974749	Synergy Closed Variable Locking Screw (VLS), Part of the Cross Medical-Synergy…	Cross Medical Products, Inc.	1998	—
+1	K982914	Aesculap Spine System Evolution: Additional Components	Aesculap, Inc.	1998	—
+1	K980484	Aesculap Spine System Evolution	Aesculap, Inc.	1998	—
+1	K990118	Isobar Spinal System	Scien'Tx USA, Inc.	1999	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1990	1	0
1992	5	0
1993	2	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1998	5	0
1999	3	0
2000	3	0
2001	1	0
2002	2	0
2003	1	0
2004	6	0
2005	3	0
2006	5	0
2007	7	0
2008	8	0
2009	6	0
2010	11	0
2011	17	0
2012	19	0
2013	22	0
2014	24	0
2015	23	0
2016	28	0
2017	31	0
2018	34	0
2019	25	0
2020	39	0
2021	32	0
2022	34	0
2023	49	0
2024	48	0
2025	49	0
2026	44	0

FIG. 1 — Lineage of K950099, 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? (14)

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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

Type	Number	Device	Applicant	Decided	Recalls
*	K901005	TSRH Spinal System (Add'l Sizes of Hooks) Summary page 2 …as materials certifications, in-house SOP's and/or ASTM Standards are utilized as appropriate. Substantially Equivalent Devices(s); 1. TSRH® Spinal System Danek Group K901005, K901587, K904243, K914306, K914966, K922520, K923242 2. PWB Lumbosacral Spinal System CROSS® Medical K920116, K924381 3. Harri…	Danek Medical, Inc.	1990	—
*	K901587	TSRH Sacral L-Connector Summary page 2 …als certifications, in-house SOP's and/or ASTM Standards are utilized as appropriate. Substantially Equivalent Devices(s); 1. TSRH® Spinal System Danek Group K901005, K901587, K904243, K914306, K914966, K922520, K923242 2. PWB Lumbosacral Spinal System CROSS® Medical K920116, K924381 3. Harrington Spi…	Danek Medical, Inc.	1990	—
*	K904243	TSRH Variable Angle Sacral Screw Summary page 2 …fications, in-house SOP's and/or ASTM Standards are utilized as appropriate. Substantially Equivalent Devices(s); 1. TSRH® Spinal System Danek Group K901005, K901587, K904243, K914306, K914966, K922520, K923242 2. PWB Lumbosacral Spinal System CROSS® Medical K920116, K924381 3. Harrington Spine System…	Danek Medical, Inc.	1992	—
*	K914306	TSRH (TM) Lateral Offset Plate Summary page 2 …, in-house SOP's and/or ASTM Standards are utilized as appropriate. Substantially Equivalent Devices(s); 1. TSRH® Spinal System Danek Group K901005, K901587, K904243, K914306, K914966, K922520, K923242 2. PWB Lumbosacral Spinal System CROSS® Medical K920116, K924381 3. Harrington Spine System Zimmer,…	Sofamor Danek Mfg., Inc.	1992	—
*	K914966	TSRH Central Post Hooks Summary page 2 …e SOP's and/or ASTM Standards are utilized as appropriate. Substantially Equivalent Devices(s); 1. TSRH® Spinal System Danek Group K901005, K901587, K904243, K914306, K914966, K922520, K923242 2. PWB Lumbosacral Spinal System CROSS® Medical K920116, K924381 3. Harrington Spine System Zimmer, Inc. Prea…	Sofamor Danek Mfg., Inc.	1992	—
*	K922520	Modified TSRH Central Post Hooks Summary page 2 …nd/or ASTM Standards are utilized as appropriate. Substantially Equivalent Devices(s); 1. TSRH® Spinal System Danek Group K901005, K901587, K904243, K914306, K914966, K922520, K923242 2. PWB Lumbosacral Spinal System CROSS® Medical K920116, K924381 3. Harrington Spine System Zimmer, Inc. Preamendment…	Sofamor Danek Mfg., Inc.	1992	—
*	K923242	Crosslink Axial and Offset Plates Summary page 2 …TM Standards are utilized as appropriate. Substantially Equivalent Devices(s); 1. TSRH® Spinal System Danek Group K901005, K901587, K904243, K914306, K914966, K922520, K923242 2. PWB Lumbosacral Spinal System CROSS® Medical K920116, K924381 3. Harrington Spine System Zimmer, Inc. Preamendment Device 4…	Sofamor Danek Mfg., Inc.	1993	—
*	K920116	PWB Lumbosacral Spine System Summary page 2 …Equivalent Devices(s); 1. TSRH® Spinal System Danek Group K901005, K901587, K904243, K914306, K914966, K922520, K923242 2. PWB Lumbosacral Spinal System CROSS® Medical K920116, K924381 3. Harrington Spine System Zimmer, Inc. Preamendment Device 4. Danck/Sofamor Group Dyna-Lok Spine System K922617, K922…	Cross Medical Products, Inc.	1992	—
*	K924381	PWB Lumbar Laminar Hooks with Set Screws Summary page 2 …t Devices(s); 1. TSRH® Spinal System Danek Group K901005, K901587, K904243, K914306, K914966, K922520, K923242 2. PWB Lumbosacral Spinal System CROSS® Medical K920116, K924381 3. Harrington Spine System Zimmer, Inc. Preamendment Device 4. Danck/Sofamor Group Dyna-Lok Spine System K922617, K922767, K923…	Cross Medical Products, Inc.	1993	—
Kept off the family tree	K922617	Dyna-Lok Spine System Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 2 …PWB Lumbosacral Spinal System CROSS® Medical K920116, K924381 3. Harrington Spine System Zimmer, Inc. Preamendment Device 4. Danck/Sofamor Group Dyna-Lok Spine System K922617, K922767, K923239, K923241 Device Description: Background: This document summarizes safety and effectiveness information about…
Kept off the family tree	K922767	Dyna-Lok Spine System Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 2 …osacral Spinal System CROSS® Medical K920116, K924381 3. Harrington Spine System Zimmer, Inc. Preamendment Device 4. Danck/Sofamor Group Dyna-Lok Spine System K922617, K922767, K923239, K923241 Device Description: Background: This document summarizes safety and effectiveness information about the SYNER…
Kept off the family tree	K923239	Dyna-Lok Spine System Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 2 …pinal System CROSS® Medical K920116, K924381 3. Harrington Spine System Zimmer, Inc. Preamendment Device 4. Danck/Sofamor Group Dyna-Lok Spine System K922617, K922767, K923239, K923241 Device Description: Background: This document summarizes safety and effectiveness information about the SYNERGY™ Poste…
Kept off the family tree	K923241	Dyna-Lok Spine System Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 2 …tem CROSS® Medical K920116, K924381 3. Harrington Spine System Zimmer, Inc. Preamendment Device 4. Danck/Sofamor Group Dyna-Lok Spine System K922617, K922767, K923239, K923241 Device Description: Background: This document summarizes safety and effectiveness information about the SYNERGY™ Posterior Spin…
*	—	Harrington Spine System Named without a submission number			—

What descends from it? (579)

See all 579

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

Number	Device	Applicant	Decided	Descendants
K973836	Synergy 6.35MM SS Rod with Screws for Anterior Use, Part of the Cross Medical-Synergy…	Cross Medical Products, Inc.	1998	529
K974749	Synergy Closed Variable Locking Screw (VLS), Part of the Cross Medical-Synergy Anterior…	Cross Medical Products, Inc.	1998	311
K982914	Aesculap Spine System Evolution: Additional Components	Aesculap, Inc.	1998	251
K980484	Aesculap Spine System Evolution	Aesculap, Inc.	1998	251
K990118	Isobar Spinal System	Scien'Tx USA, Inc.	1999	250
K090523	Polaris Spinal System	Ebi, L.P.	2009	156
K100409	Polaris Spinal System, Polaris/Synergy Structue Anterior Fixation System	Biomet Spine (Aka Ebi, LLC)	2010	144
K101278	Inertia Pedicle Screw System	Nexxt Spine, LLC	2010	111
K100438	Polaris Spinal System, Polaris/Synergy Structure Anterior Fixation System	Ebi, L.P.	2010	104
K133746	Polaris Spinal System	Biomet Spine (Aka Ebi, LLC)	2014	67

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?

None of the 9 ancestors has a recall.
Of its descendants, K973836 (Cross Medical Products, Inc., 1998) has gone furthest, with 529 descendants of its own.

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.

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 SYNERGY™ Posterior Spinal System, when using the screws as pedicle screws, is intended only for patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lambarfirst sacral (L5-81) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the screws fixed or attached to the lumbar and sacral spine; and (d) who are having the device removed after the development of a solid fusion mass. Except…

Read the full statement (269 words)

Except for situations where screws are attached to the pedicles of the lumbar and sacral spine via a posterior. approach for the treatment of severe spondylolisthesis (Grade 3 and Grade 4) at the L5-51 vertebral joint, the specific indications for the SYNERGY™ Posterior Spinal System are:

1. Degenerative Disc Disease (as defined by chronic back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies).

2. Idiopathic scoliosis.

Kyphotic deformities of the spine.

Paralytic scoliosis and/or pelvic obliquity treated in combination with anterior instrumentation.

Lordotic deformities of the spine.

Neuromuscular scoliosis associated with pelvic obliquity.

Vertebral fracture or dislocation.

Tumors.

Spondylolisthesis.

10. Stenosis.

11. Pseudarthrosis.

12. Unsuccessful previous attempts at spinal fusion.

For these indications, the SYNERGY™ screws and lateral connectors are intended for sacral/iliac attachment only. All of the SYNERGY™ hooks and transverse connectors are intended for posterior thoracic and/or lumbar use only. As a whole, the levels of use for the SYNERGY™ Posterior Spinal System are T1 to the Sacrum. The levels of screw fixation are L3 to ilium.

Note: The 4.75 mm diameter rod/hook constructs are intended only for patients weighing 70 pounds (32 kg) or less.

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/K950099 · printed Nov 5, 2026

Cite this page

510(k) Report. “K950099: Synergy (TM) TI Posterior Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K950099

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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