510(k) Report

510(k) · Cleared

Cleared

Zimmer Segmental System

K192798510(k) TraditionalCleared Dec 10, 2020437-day reviewClass II21 CFR 888.3510

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

Zimmer, Inc. · KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer

Cleared on Dec 10, 2020 as substantially equivalent to K070978 (Zimmer, Inc., 2007) and 5 other predicates after a 437-day review. Its family tree reaches back 5 generations to 1996.

Decided
Dec 10, 2020
Review
437 days
Class
Class II
Product code
KRO
Recalls
None
Predicates
6

Its longest line of descent runs back 5 generations to K945028 (1996). 20 ancestors in all, the oldest K870730 (1987). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2015: 1 other ancestor2010: 1 other ancestor2008: 1 other ancestor2001: 1 other ancestor2000: 1 other ancestor1997: 3 other ancestors1996: 1 other ancestor1998: 1 other ancestor1994: 1 other ancestor1993: 1 other ancestor1991: 1 other ancestor1990: 1 other ancestor1987: 1 other ancestorK945028 · Finn Knee System · Biomet, Inc. · 1996K013385 · Nexgen Complete Knee Solution Rotatng Hinge Knee · Zimmer, Inc. · 2002 · recalledK070978 · Zimmer Segmental System · Zimmer, Inc. · 2007 · recalledK110940 · Zimmer Segment System Trabecular Metal Proximal Tibial Component, Trabecular Metal Proximal Component, Additional Segmen · Zimmer, Inc. · 2011K183136 · Zimmer Segmental System Proximal Femoral Component · Zimmer, Inc. · 20191990200020102020
Other ancestors, by generation 1 generation back: 3 other ancestors2 generations back: 5 other ancestors3 generations back: 7 other ancestors K183136 · Zimmer Segmental System Proximal Femoral Component · Zimmer, Inc. · 2019K110940 · Zimmer Segment System Trabecular Metal Proximal Tibial Component, Trabecular Metal Proximal Component, Additional Segmen · Zimmer, Inc. · 2011K070978 · Zimmer Segmental System · Zimmer, Inc. · 2007 · recalledK013385 · Nexgen Complete Knee Solution Rotatng Hinge Knee · Zimmer, Inc. · 2002 · recalledK945028 · Finn Knee System · Biomet, Inc. · 1996−50
  1. Root · 5 generations backK945028 Finn Knee SystemBiomet, Inc. · 1996
  2. 4 generations backK013385 Nexgen Complete Knee Solution Rotatng Hinge KneeZimmer, Inc. · 2002 · Recalled
  3. 3 generations backK070978 Zimmer Segmental SystemZimmer, Inc. · 2007 · Recalled
  4. 2 generations backK110940 Zimmer Segment System Trabecular Metal Proximal Tibial Component…Zimmer, Inc. · 2011
  5. 1 generation backK183136 Zimmer Segmental System Proximal Femoral ComponentZimmer, Inc. · 2019
  6. This deviceK192798 Zimmer Segmental SystemZimmer, Inc. · 2020
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K945028Finn Knee SystemBiomet, Inc.1996—
−4K013385Nexgen Complete Knee Solution Rotatng Hinge KneeZimmer, Inc.20022
−3K070978Zimmer Segmental SystemZimmer, Inc.20076
−2K110940Zimmer Segment System Trabecular Metal Proximal Tibial Component, Trabecular…Zimmer, Inc.2011—
−1K183136Zimmer Segmental System Proximal Femoral ComponentZimmer, Inc.2019—
0 (this device)K192798Zimmer Segmental SystemZimmer, Inc.2020—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198710
199010
199110
199310
199410
199610
199730
199810
200010
200110
200810
201010
201510
FIG. 1 — Lineage of K192798, 1996–2020Source: 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), 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 KRO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new KRO device

  1. #1 K251665 Triathlon® Hinge Knee Systemscore 19.0 · 12 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (6)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K070978Zimmer Segmental System
Summary page 5
…e 5 === K192798 Predicate Device(s): Zimmer Segmental System K070978 K081860 K10…
Zimmer, Inc.20076
*K081860Zimmer Segmental System Variable Stiffness Stem Extensions and Intercalary Segments
Summary page 5
…K192798 Predicate Device(s): Zimmer Segmental System K070978 K081860 K101296 K11…
Zimmer, Inc.20081
*K101296Zimmer Segmental System Proximal Femoral Component and Small Diameter Stem Extensions
Summary page 5
…Zimmer Segmental System K070978 K081860 K101296 K110940 K15…
Zimmer, Inc.20102
*K110940Zimmer Segment System Trabecular Metal Proximal Tibial Component, Trabecular Metal…
Summary page 5
…K081860 K101296 K110940 K150028 K18…
Zimmer, Inc.2011—
*K150028Zimmer Segmental System XT Components
Summary page 5
…K101296 K110940 K150028 K183136 Purpose and Device Description: The purpose of th…
Zimmer, Inc.2015—
*K183136Zimmer Segmental System Proximal Femoral Component
Summary page 5
…K110940 K150028 K183136 Purpose and Device Description: The purpose of this submission is an addition of the MR condi…
Zimmer, Inc.2019—

Also cleared against K070978: 4 other devices →

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.

What does this lineage say?

  • The line of descent spans 24 years and passes through 2 companies; a new generation was cleared every 5.5 years on median.
  • 6 of the 20 ancestors have a recall of any class.
  • 4 other devices also cite its predicate K070978.

How does its category compare?

All KRO devices

KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.

FDA decisions per year · KRO

3in 2025

2007: 12008: 32009: 32010: 12011: 22012: 22013: 32014: 22015: 62016: 32017: 12019: 32020: 12021: 32022: 12023: 42024: 32025: 32026 (partial year): 1
2007high 6 (2015) · low 0 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KRO

56in 2025

2008: 126 days median2009: 86 days median2013: 189 days median2015: 113 days median2016: 148 days median2019: 244 days median2021: 57 days median2023: 148 days median2024: 87 days median2025: 56 days median
2007high 244 (2019) · low 56 (2025)2026

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

Recalls per year · KRO

14so far in 2026, the most since 2007

2007: 12008: 32009: 82011: 12012: 12013: 22015: 12016: 52017: 42018: 12021: 12025: 12026 (partial year): 14
2007high 14 (2026) · low 0 (2010)2026

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

Adverse event reports per year · KRO

915in 2025

2007: 372008: 442009: 662010: 1102011: 1192012: 1732013: 1942014: 4062015: 3332016: 3692017: 5432018: 6142019: 7592020: 7492021: 7702022: 8922023: 7462024: 8552025: 915
2007high 915 (2025) · low 37 (2007)2025

MAUDE reports naming product code KRO, 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
20071—137
20083126344
2009386866
20101—0110
20112—1119
20122—1173
201331892194
20142—0406
201561131333
201631485369
20171—4543
20180—1614
201932440759
20201—0749
20213571770
20221—0892
202341480746
20243870855
20253561915
20261—14—

What is it indicated for?

This device is indicated for: - Moderate to severe knee instability - Significant bone loss and/or ligament deficiencies caused by neoplasms, trauma, rheumatoid arthritis, ostcoarthritis, traumatic arthritis, polyarthritis, collagen disorders, and/or avascular necrosis of the proximal and/or distal femur and/or proximal tibia - Valgus, varus or flexion deformities - The salvage of previously failed surgical attempts * A total femoral replacement…

Read the full statement (201 words)

This device is indicated for:

- Moderate to severe knee instability

- Significant bone loss and/or ligament deficiencies caused by neoplasms, trauma, rheumatoid arthritis, ostcoarthritis, traumatic arthritis, polyarthritis, collagen disorders, and/or avascular necrosis of the proximal and/or distal femur and/or proximal tibia

- Valgus, varus or flexion deformities

- The salvage of previously failed surgical attempts

* A total femoral replacement construct consisting of Segmental proximal fernoral, Segmental System segments and Segmental System distal femoral components may be used without cement.

* Variable Stiffness stem extensions require the use of either a smooth or Trabecular Metal stem collar, which must be cemented to the stem. Following cementing to the stem, the smooth collar must be cemented against the bone. The remainder of the stem must be used uncemented.

* Fluted stem extensions require the use of either a smooth or Trabecular Metal stem collar, which must be cemented to the stem. Following cementing to the stem extension, the smooth collar must be cemented against the bone. The remainder of the stem must also be cemented against the bone.

* The Trabecular Metal collar may be used cemented or uncemented against the bone.

* All other constructs are for cemented use only.

Indications for use as stated in the FDA summary.

Also cleared against K070978

4 other devices cite the same predicate.

  • K190100USTAR II SystemUnited Orthopedic Corporation · 20195 recalls
  • K150028Zimmer Segmental System XT ComponentsZimmer, Inc. · 2015
  • K110940Zimmer Segment System Trabecular Metal Proximal Tibial Component, Trabecular Metal Proximal Component…Zimmer, Inc. · 2011
  • K081860Zimmer Segmental System Variable Stiffness Stem Extensions and Intercalary SegmentsZimmer, Inc. · 20081 recall

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 KRO

The KRO category page

  • K261898Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee SystemHowmedica Osteonics Corp. dba Stryker Orthopaedics · 2026
  • K252898Triathlon® Tritanium® Asymmetric Patella; Triathlon® Tritanium® Symmetric Patella; Triathlon® Symmetric…Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 20251 recall
  • K252303Stem Extension Line (USTAR II System)United Orthopedic Corporation · 2025
  • K251665Triathlon® Hinge Knee SystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2025
  • K242871ATTUNE™ Revision Hinge KneeDepuy Ireland UC · 202411 recalls

https://510kreport.com/device/K192798 · printed Nov 6, 2026

Cite this page

510(k) Report. “K192798: Zimmer Segmental System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192798

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026