# K950099: Synergy (TM) TI Posterior Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Buckman Co., Inc.
- Decided: Jan 16, 1997 after 737 days
- Product code: MNH (Orthosis, Spondylolisthesis Spinal Fixation)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K901587 (1990). 9 ancestors in all.
579 later devices descend from it; 35 cite it directly.
0 of 589 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K901005: TSRH Spinal System (Add'l Sizes of Hooks), Danek Medical, Inc. (1990) Summary page 2.
- K901587: TSRH Sacral L-Connector, Danek Medical, Inc. (1990) Summary page 2.
- K904243: TSRH Variable Angle Sacral Screw, Danek Medical, Inc. (1992) Summary page 2.
- K914306: TSRH (TM) Lateral Offset Plate, Sofamor Danek Mfg., Inc. (1992) Summary page 2.
- K914966: TSRH Central Post Hooks, Sofamor Danek Mfg., Inc. (1992) Summary page 2.
- K922520: Modified TSRH Central Post Hooks, Sofamor Danek Mfg., Inc. (1992) Summary page 2.
- K923242: Crosslink Axial and Offset Plates, Sofamor Danek Mfg., Inc. (1993) Summary page 2.
- K920116: PWB Lumbosacral Spine System, Cross Medical Products, Inc. (1992) Summary page 2.
- K924381: PWB Lumbar Laminar Hooks with Set Screws, Cross Medical Products, Inc. (1993) Summary page 2.
- (no number) Harrington Spine System: named in the summary without a submission number

## Cited in the summary but 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.
- 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.
- 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.
- 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.

## Most influential descendants
- K973836: Synergy 6.35MM SS Rod with Screws for Anterior Use, Part of the Cross Medical-Synergy Anterior Spinal System (1998), 529 descendants of its own
- K974749: Synergy Closed Variable Locking Screw (VLS), Part of the Cross Medical-Synergy Anterior and Posterior Spinal Systems (1998), 311 descendants of its own
- K982914: Aesculap Spine System Evolution: Additional Components (1998), 251 descendants of its own
- K980484: Aesculap Spine System Evolution (1998), 251 descendants of its own
- K990118: Isobar Spinal System (1999), 250 descendants of its own

## Indications for use
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 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.

Source page: https://510kreport.com/device/K950099
Methodology: https://510kreport.com/methodology