510(k) Report

510(k) · Cleared

Cleared

Rogozinski Spinal Rod System Rod-to-Bolt (Universal) Connector for Use with the Simmons Plating System Bolt

K950865510(k) TraditionalCleared Sep 1, 1995186-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

Smith & Nephew Richards, Inc. · MNH Orthosis, Spondylolisthesis Spinal Fixation

Cleared on Sep 1, 1995 after a 186-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 28 later devices descend from it.

Decided
Sep 1, 1995
Review
186 days
Class
Class II
Product code
MNH
Recalls
None
Predicates
0

28 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 1998: 1 descendant cleared2010: 1 descendant cleared2003: 1 descendant cleared2013: 4 descendants cleared2011: 3 descendants cleared2012: 1 descendant cleared2017: 3 descendants cleared2015: 1 descendant cleared2016: 1 descendant cleared2022: 1 descendant cleared2025: 3 descendants cleared2020: 1 descendant cleared2014: 1 descendant cleared2018: 1 descendant cleared2024: 1 descendant cleared2026: 3 descendants cleared2023: 1 descendant cleared1995200020052010201520202025
  1. This deviceK950865 Rogozinski Spinal Rod System Rod-to-Bolt (Universal) Connector for…Smith & Nephew Richards, Inc. · 1995
  2. Descendant · cites it directly · 27 of its ownK983904 Rogozinski Spinal Rod SystemUnited States Surgical, A Division of Tyco Healthc · 1998
  3. Descendant · 2 generations on · 14 of its ownK031595 U & I America Spinal Hook SystemU&I Corp., America · 2003 · Recalled
  4. Descendant · 2 generations on · 9 of its ownK100757 Tilock Pedicle Screw SystemGenesys Spine · 2010 · Recalled
  5. Descendant · 3 generations on · 8 of its ownK103671 Genesys Spine Tilock SystemGenesys Spine · 2011
  6. Descendant · 3 generations on · 7 of its ownK152039 Genesys Spine TiLock2 Spinal SystemGenesys Spine · 2015

Showing 5 of 28 descendants. See all descendants

Descendants cleared per year

1998: 12003: 12010: 12011: 32012: 12013: 42014: 12015: 12016: 12017: 32018: 12020: 12022: 12023: 12024: 12025: 32026: 3
1998high 4 (2013) · low 0 (1999)2026

Most influential descendants

Showing 5 of 28 · See all
  • K983904Rogozinski Spinal Rod SystemUnited States Surgical, A Division of Tyco Healthc · 1998 · cites it directly27descendants
  • K031595U & I America Spinal Hook SystemU&I Corp., America · 2003 · 2 generations on14descendants
  • K100757Tilock Pedicle Screw SystemGenesys Spine · 2010 · 2 generations on9descendants
  • K103671Genesys Spine Tilock SystemGenesys Spine · 2011 · 3 generations on8descendants
  • K152039Genesys Spine TiLock2 Spinal SystemGenesys Spine · 2015 · 3 generations on7descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K950865Rogozinski Spinal Rod System Rod-to-Bolt (Universal) Connector for Use with…Smith & Nephew Richards, Inc.1995—
+1K983904Rogozinski Spinal Rod SystemUnited States Surgical, A Division of Tyco Healthc1998—
+2K031595U & I America Spinal Hook SystemU&I Corp., America20033
+2K100757Tilock Pedicle Screw SystemGenesys Spine20101
+3K103671Genesys Spine Tilock SystemGenesys Spine2011—
+3K152039Genesys Spine TiLock2 Spinal SystemGenesys Spine2015—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199810
200310
201010
201130
201210
201340
201410
201510
201610
201730
201810
202010
202210
202310
202410
202530
202630
FIG. 1 — Lineage of K950865, 1995–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), 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
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (28)

See all 28

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K983904Rogozinski Spinal Rod SystemUnited States Surgical, A Division of Tyco Healthc199827

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?

  • Of its descendants, K983904 (United States Surgical, A Division of Tyco Healthc, 1998) has gone furthest, with 27 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

2007: 52008: 132009: 132010: 102011: 172012: 72013: 102014: 122015: 102016: 8
2007high 17 (2011) · low 0 (2017)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MNH

93in 2016

2007: 123 days median2008: 65 days median2009: 151 days median2010: 106 days median2011: 171 days median2012: 93 days median2013: 124 days median2014: 140 days median2015: 99 days median2016: 93 days median
2007high 171 (2011) · low 65 (2008)2026

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

Recalls per year · MNH

1in 2016

2009: 72012: 12013: 12016: 1
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

2007: 182008: 302009: 452010: 592011: 1072012: 4332013: 4642014: 2862015: 1522016: 2162017: 1742018: 1292019: 4032020: 4322021: 5312022: 2652023: 1212024: 3022025: 89
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20075123018
20081365030
200913151745
201010106059
2011171710107
20127931433
2013101241464
2014121400286
201510990152
20168931216
20170—0174
20180—0129
20190—0403
20200—0432
20210—0531
20220—0265
20230—0121
20240—0302
20250—089
20260—0—

More from Smith & Nephew Richards, Inc.

93 FDA decisions under this applicant name. See the company

  • P810020/S005OsteopalSmith & Nephew Richards, Inc. · 1998
  • P810020/S004Palacos E-Flow (Osteopal) Bone CementSmith & Nephew Richards, Inc. · 1998
  • K965224Empower Anterior Direct ScrewsSmith & Nephew Richards, Inc. · 1997
  • K963509Global Taper Tapered Hip System, GT SpectronSmith & Nephew Richards, Inc. · 1997
  • K960444Finn Rod to Rod ConnectorSmith & Nephew Richards, Inc. · 1997

Recent decisions in MNH

The MNH category page

  • K162066Reliance Spinal Screw SystemReliance Medical Systems, LLC · 2016
  • K162801CastleLoc Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2016
  • K162143FixxSure® X-LinkInnovasis, Inc. · 2016
  • K161151Spinal fixation systemCanwell Medical Co., Ltd. · 2016
  • K162189ANAX™ 5.5 Spinal SystemU&I Corporation · 2016

https://510kreport.com/device/K950865 · printed Nov 6, 2026

Cite this page

510(k) Report. “K950865: Rogozinski Spinal Rod System Rod-to-Bolt (Universal) Connector for Use with the Simmons Plating System Bolt.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K950865

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026