510(k) · Cleared
ClearedFinn Rod to Rod Connector
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew Richards, Inc. · KWP Appliance, Fixation, Spinal Interlaminal
Cleared on Jan 24, 1997 after a 358-day review. The FDA summary names its predicate without a number.
- Decided
- Jan 24, 1997
- Review
- 358 days
- Class
- Class II
- Product code
- KWP
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
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 KWP? 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
What was it cleared against? (5)
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 |
|---|---|---|---|
| * | — | AcroMed Modular Cross Connector Components Named without a submission number | |
| * | — | Dyna-Lok Spinal System Crosslink Plate Named without a submission number | |
| * | — | TSRH Spinal System Crosslink Named without a submission number | |
| * | — | Isola Spinal System transverse rod connectors Named without a submission number | |
| * | — | Rogozinski Spinal Rod System crossbar Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
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.
How does its category compare?
All KWP devicesKWP Appliance, Fixation, Spinal Interlaminal: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KWP
9in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · KWP
113in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWP
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWP
494in 2025
MAUDE reports naming product code KWP, 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 | 14 | 96 | 2 | 210 |
| 2008 | 13 | 50 | 1 | 594 |
| 2009 | 12 | 89 | 23 | 682 |
| 2010 | 14 | 186 | 2 | 474 |
| 2011 | 12 | 67 | 6 | 792 |
| 2012 | 18 | 112 | 1 | 918 |
| 2013 | 12 | 99 | 3 | 1,090 |
| 2014 | 13 | 138 | 0 | 1,022 |
| 2015 | 9 | 113 | 1 | 1,348 |
| 2016 | 0 | — | 3 | 1,379 |
| 2017 | 0 | — | 0 | 864 |
| 2018 | 0 | — | 1 | 657 |
| 2019 | 0 | — | 2 | 518 |
| 2020 | 0 | — | 0 | 796 |
| 2021 | 0 | — | 0 | 525 |
| 2022 | 0 | — | 2 | 335 |
| 2023 | 0 | — | 0 | 332 |
| 2024 | 0 | — | 0 | 436 |
| 2025 | 0 | — | 0 | 494 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Finn Rod to Rod Connector is used as part of the Rogozinski Spinal Rod System. The Rod to Rod Connector is designed to attach two 1/4* Rogozinski Spinal Rods to provide temporary stability to the lumbosacral spine during the development of a solid spinal fusion. The Finn Rod to Rod Connectors are designed to be part of a construct that consists of Rogozinski rods attached to the spine with hooks, bolts and/or screws. The Finn Rod to Rod Connectors…
Read the full statement (262 words)
The Finn Rod to Rod Connector is used as part of the Rogozinski Spinal Rod System. The Rod to Rod Connector is designed to attach two 1/4* Rogozinski Spinal Rods to provide temporary stability to the lumbosacral spine during the development of a solid spinal fusion. The Finn Rod to Rod Connectors are designed to be part of a construct that consists of Rogozinski rods attached to the spine with hooks, bolts and/or screws. The Finn Rod to Rod Connectors when used in constructs with spinal screws or bolts placed in the pedicles are intended only for patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar - first sacral (L5-S1) vertebral 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; and (d) who are having the device removed after the development of a solid fusion mass. Otherwise, the Finn Rod to Rod Connectors when used in constructs with spinal screws or bolts are intended for sacral iliac attachment only in the treatment of degenerative disc disease of the lumbar spine, pseudoarthrosis, spinal stenosis, scoliosis, spondylolisthesis, fracture, failed back syndrome/unsuccessful previous attempts at spinal fusion, or tumor resection. Degenerative disc disease of the lumbar spine is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.
The Rogozinski System is limited to noncervical spine use. The levels of pedicle screw / bolt use for this system are limited to L3-S1 or iliac screw fixation.
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/K960444 · printed Nov 6, 2026
Cite this page
510(k) Report. “K960444: Finn Rod to Rod Connector.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K960444
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)
- Page last updated Nov 3, 2026