510(k) Report

510(k) · Cleared

Cleared

Zimmer Threaded Acetabular Cup

K850766510(k) TraditionalCleared May 1, 198565-day reviewClass III21 CFR 888.3330

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

Zimmer, Inc. · KWA Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)

Cleared on May 1, 1985 after a 65-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 13 later devices descend from it.

Decided
May 1, 1985
Review
65 days
Class
Class III
Product code
KWA
Recalls
None
Predicates
0

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

Descendants, by year cleared 2012: 1 descendant cleared2018: 2 descendants cleared2019: 3 descendants cleared2015: 1 descendant cleared2025: 2 descendants cleared2014: 1 descendant cleared2016: 1 descendant cleared2017: 1 descendant cleared2020: 1 descendant cleared1990200020102020
  1. This deviceK850766 Zimmer Threaded Acetabular CupZimmer, Inc. · 1985
  2. Descendant · cites it directly · 12 of its ownK112898 Delta TT Cups, Delta TT Liners, Bone ScrewsLima Corporate S.P.A. · 2012
  3. Descendant · 2 generations on · 10 of its ownK141395 Delta TT Acetabular SystemLima Corporate S.P.A. · 2014 · Recalled
  4. Descendant · 2 generations on · 3 of its ownK182099 Delta TT ProLima Corporate S.P.A. · 2018
  5. Descendant · 3 generations on · 2 of its ownK191622 Delta Multihole TT Pro Acetabular SystemLima Corporate S.P.A. · 2019
  6. Descendant · 2 generations on · 2 of its ownK150855 H-MAX S Femoral Hip SystemLima Corporate S.P.A. · 2015

Showing 5 of 13 descendants. See all descendants

Descendants cleared per year

2012: 12014: 12015: 12016: 12017: 12018: 22019: 32020: 12025: 2
2012high 3 (2019) · low 0 (2013)2026

Most influential descendants

Showing 5 of 13 · See all
  • K112898Delta TT Cups, Delta TT Liners, Bone ScrewsLima Corporate S.P.A. · 2012 · cites it directly12descendants
  • K141395Delta TT Acetabular SystemLima Corporate S.P.A. · 2014 · 2 generations on10descendants
  • K182099Delta TT ProLima Corporate S.P.A. · 2018 · 2 generations on3descendants
  • K191622Delta Multihole TT Pro Acetabular SystemLima Corporate S.P.A. · 2019 · 3 generations on2descendants
  • K150855H-MAX S Femoral Hip SystemLima Corporate S.P.A. · 2015 · 2 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K850766Zimmer Threaded Acetabular CupZimmer, Inc.1985—
+1K112898Delta TT Cups, Delta TT Liners, Bone ScrewsLima Corporate S.P.A.2012—
+2K141395Delta TT Acetabular SystemLima Corporate S.P.A.20141
+2K182099Delta TT ProLima Corporate S.P.A.2018—
+3K191622Delta Multihole TT Pro Acetabular SystemLima Corporate S.P.A.2019—
+2K150855H-MAX S Femoral Hip SystemLima Corporate S.P.A.2015—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201210
201410
201510
201610
201710
201820
201930
202010
202520
FIG. 1 — Lineage of K850766, 1985–2025Source: 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 KWA? 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? (13)

See all 13

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

NumberDeviceApplicantDecidedDescendants
K112898Delta TT Cups, Delta TT Liners, Bone ScrewsLima Corporate S.P.A.201212

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, K112898 (Lima Corporate S.P.A., 2012) has gone furthest, with 12 descendants of its own.

How does its category compare?

All KWA devices

KWA Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KWA

4in 2012

2007: 82008: 92009: 72010: 62011: 112012: 4
2007high 11 (2011) · low 0 (2013)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KWA

76in 2012

2007: 74 days median2008: 57 days median2009: 139 days median2010: 167 days median2011: 101 days median2012: 76 days median
2007high 167 (2010) · low 57 (2008)2026

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

Recalls per year · KWA

19in 2023

2008: 132010: 842011: 282012: 212013: 12016: 12017: 12018: 12019: 22020: 12023: 19
2007high 84 (2010) · low 0 (2007)2026

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

Adverse event reports per year · KWA

1,216in 2025

2007: 2132008: 7622009: 8202010: 3,3482011: 17,7372012: 24,6012013: 20,0202014: 16,4942015: 12,3392016: 7,8722017: 6,8472018: 6,3882019: 7,6282020: 4,5382021: 2,0642022: 1,6172023: 1,4742024: 1,1682025: 1,216
2007high 24,601 (2012) · low 213 (2007)2025

MAUDE reports naming product code KWA, 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
20078740213
200895713762
200971390820
20106167843,348
2011111012817,737
20124762124,601
20130—120,020
20140—016,494
20150—012,339
20160—17,872
20170—16,847
20180—16,388
20190—27,628
20200—14,538
20210—02,064
20220—01,617
20230—191,474
20240—01,168
20250—01,216
20260—0—

More from Zimmer, Inc.

524 FDA decisions under this applicant name. See the company

  • P060037/S100NexGen® LPS-Flex/LPS Mobile Bearing Knee SystemZimmer, Inc. · 2026
  • P060037/S099NexGen LPS-Flex Mobile and LPS-Mobile Bearing Knee SystemZimmer, Inc. · 2026
  • K262955OsseoFit Stemless Shoulder SystemZimmer, Inc. · 2026
  • P060037/S097Creep Pressure Test Update for the Nexgen LPS Bearing KneeZimmer, Inc. · 2026
  • P060037/S098Nexgen LPS Femoral and Tibial Knee componentsZimmer, Inc. · 2026

Recent decisions in KWA

The KWA category page

  • K122778Profemur Z Revision Hip StemWrightmedicaltechnologyinc · 2012
  • K121544Dynasty Biofoam ShellWrightmedicaltechnologyinc · 2012
  • K113271Metal-on-Metal Hip Systems-Additional ContraindicationsBiomet Manufacturing, Inc. · 2012
  • K113322Conserve Thin ShellWrightmedicaltechnologyinc · 2012
  • K112080Preserve Hip StemWrightmedicaltechnologyinc · 2011

https://510kreport.com/device/K850766 · printed Nov 4, 2026

Cite this page

510(k) Report. “K850766: Zimmer Threaded Acetabular Cup.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K850766

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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