# K983904: Rogozinski Spinal Rod System

- Pathway: 510(k) (Traditional)
- Applicant: United States Surgical, A Division of Tyco Healthc
- Decided: Dec 22, 1998 after 49 days
- Product code: KWP (Appliance, Fixation, Spinal Interlaminal)
- Device class: 2
- Regulation: 21 CFR 888.3050
- 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 K884263 (1988). 5 ancestors in all.
27 later devices descend from it; 4 cite it directly.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K884263: Rogozinski Spinal System, Richards Medical Co., Inc. (1988) Summary page 1.
- K896106: Rogozinski Spinal System, Add'l Components, Richards Medical Co., Inc. (1990) Summary page 1.
- K930298: Rogozinski Spinal Rod System Screw, Smith & Nephew Richards, Inc. (1995) Summary page 1.
- K950865: Rogozinski Spinal Rod System Rod-to-Bolt (Universal) Connector for Use with the Simmons Plating System Bolt, Smith & Nephew Richards, Inc. (1995) Summary page 1.
- K965224: Empower Anterior Direct Screws, Smith & Nephew Richards, Inc. (1997) Summary page 1.

## Cited in the summary but kept off the family tree
- K854696: OP II Visible Light Curing System, Almore Intl., Inc. (1986). Our OCR of the scanned summary read K854696, FDA’s number for OP II Visible Light Curing System (Almore Intl., Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “USSC's Surgical Dynamics™ Rogozinski Spinal Rod System”. Kept off the family tree. Summary page 1.

## Most influential descendants
- K031595: U & I America Spinal Hook System (2003), 14 descendants of its own
- K100757: Tilock Pedicle Screw System (2010), 9 descendants of its own
- K103671: Genesys Spine Tilock System (2011), 8 descendants of its own
- K152039: Genesys Spine TiLock2 Spinal System (2015), 7 descendants of its own
- K113324: Rexious Hook Fixation Systems (2012), 6 descendants of its own

## Indications for use
Non-Pedicle Screw Fixation Whan used as an anterior spinal system the Rogozinski Spinal Rod System is intended for the treatement of DDD (degenerative disc disease defined as back pain of discogenic origin with degeneration of the disc confirmed by history or radiographic studies), pseudoarthrosis, stenosis, deformities (scoliosis, Kyphosis, lordosis), spondylolisthesis, fracture, previous failed fusion, or tumor resection. The Rogozinski Spinal Red System is limited to non-cervical use. When used as a posterior, non-pedicle spinal system (consisting of hooks and sacralflliac scraws), the Rogozinski Spinal Rod System is intended for the treatement of ODD (degenerative disc disease defined as back pain of discogenic origin with degeneration of the disc confirmed by history or radiographic studies), pseudoarthrosis, stenosis, deformities (scoliosis, kyphosis, lordosis), spondylolisthesis, fracture, previous failed fusion, or tumor resection. The Rogozinski Spinal Rod System is limited to non-cervical use. Pedicle Screw Fixation When used as a pedicle screw system, in the spine of skeletally mature patients, the Rogozinski Spinal Rod System is indicated for patients: (a) having severe spondylolisthesis (Grades 3 and 4) at the L5-S1 joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (d) who are having the device removed after the development of a solid fusion mass. In addition, when used as a pedicle screw system, in the non-cervical spine of skeletally mature patients, the Rogozinski Spinal Rod System is intended to provide immabilization and stabilization of spinal segments, as an adjunct to fusion, in the treatment of the following acute and chronic instabilites of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neuroclogic impairment, fracture, dislocation, scofiosis, kyphosis, spinal tumor, and failed previous fusion (pseudarhrosis).

Source page: https://510kreport.com/device/K983904
Methodology: https://510kreport.com/methodology