510(k) Report

510(k) · Cleared

Cleared

Rogozinski Spinal System

K884263510(k) TraditionalCleared Dec 29, 198879-day reviewClass II21 CFR 888.3050

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

Richards Medical Co., Inc. · KWP Appliance, Fixation, Spinal Interlaminal

Cleared on Dec 29, 1988 after a 79-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 37 later devices descend from it.

Decided
Dec 29, 1988
Review
79 days
Class
Class II
Product code
KWP
Recalls
None
Predicates
0

37 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 1998: 1 descendant cleared2010: 2 descendants cleared2017: 6 descendants cleared2020: 2 descendants cleared2003: 1 descendant cleared2013: 4 descendants cleared2011: 3 descendants cleared2012: 1 descendant cleared2015: 1 descendant cleared2016: 1 descendant cleared2022: 1 descendant cleared2025: 5 descendants cleared2023: 3 descendants cleared2014: 1 descendant cleared2018: 1 descendant cleared2024: 1 descendant cleared2026: 3 descendants cleared1990200020102020
  1. This deviceK884263 Rogozinski Spinal SystemRichards Medical Co., Inc. · 1988
  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 · cites it directly · 8 of its ownK101682 S 100 Pedicle Screw SystemRenovis Surgical Technologies, LLC · 2010

Showing 5 of 37 descendants. See all descendants

Descendants cleared per year

1998: 12003: 12010: 22011: 32012: 12013: 42014: 12015: 12016: 12017: 62018: 12020: 22022: 12023: 32024: 12025: 52026: 3
1998high 6 (2017) · low 0 (1999)2026

Most influential descendants

Showing 5 of 37 · 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
  • K101682S 100 Pedicle Screw SystemRenovis Surgical Technologies, LLC · 2010 · cites it directly8descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K884263Rogozinski Spinal SystemRichards Medical Co., Inc.1988—
+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—
+1K101682S 100 Pedicle Screw SystemRenovis Surgical Technologies, LLC2010—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199810
200310
201020
201130
201210
201340
201410
201510
201610
201760
201810
202020
202210
202330
202410
202550
202630
FIG. 1 — Lineage of K884263, 1988–2026Source: 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 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
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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? (37)

See all 37

2 later devices cite 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
K101682S 100 Pedicle Screw SystemRenovis Surgical Technologies, LLC20108

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 KWP devices

KWP Appliance, Fixation, Spinal Interlaminal: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KWP

9in 2015

2007: 142008: 132009: 122010: 142011: 122012: 182013: 122014: 132015: 9
2007high 18 (2012) · low 0 (2016)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KWP

113in 2015

2007: 96 days median2008: 50 days median2009: 89 days median2010: 186 days median2011: 67 days median2012: 112 days median2013: 99 days median2014: 138 days median2015: 113 days median
2007high 186 (2010) · low 50 (2008)2026

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

Recalls per year · KWP

2in 2022

2007: 22008: 12009: 232010: 22011: 62012: 12013: 32015: 12016: 32018: 12019: 22022: 2
2007high 23 (2009) · low 0 (2014)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · KWP

494in 2025

2007: 2102008: 5942009: 6822010: 4742011: 7922012: 9182013: 1,0902014: 1,0222015: 1,3482016: 1,3792017: 8642018: 6572019: 5182020: 7962021: 5252022: 3352023: 3322024: 4362025: 494
2007high 1,379 (2016) · low 210 (2007)2025

MAUDE reports naming product code KWP, 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
200714962210
200813501594
2009128923682
2010141862474
201112676792
2012181121918
2013129931,090
20141313801,022
2015911311,348
20160—31,379
20170—0864
20180—1657
20190—2518
20200—0796
20210—0525
20220—2335
20230—0332
20240—0436
20250—0494
20260—0—

More from Richards Medical Co., Inc.

71 FDA decisions under this applicant name. See the company

  • K896106Rogozinski Spinal System, Add'l ComponentsRichards Medical Co., Inc. · 1990
  • K900628Modular Hip SystemRichards Medical Co., Inc. · 1990
  • K896580Uni-Polar HeadRichards Medical Co., Inc. · 1990
  • K895241Intramedullary Hip ScrewRichards Medical Co., Inc. · 1990
  • K884824Tricon-M Total Knee SystemRichards Medical Co., Inc. · 1989

Recent decisions in KWP

The KWP category page

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  • K150753OASYS SystemStryker Corporation · 2015
  • K150851Sure Lok Mini Posterior Cervical/Upper Thoracic SystemPrecision Spine, Inc. · 2015
  • K142867Reliance Posterior Cervical-Thoracic SystemReliance Medical Systems, LLC · 2015
  • K150254Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) · 20153 recalls

https://510kreport.com/device/K884263 · printed Nov 6, 2026

Cite this page

510(k) Report. “K884263: Rogozinski Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K884263

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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