510(k) · Cleared

Cleared

Zimmer Segment System Trabecular Metal Proximal Tibial Component, Trabecular Metal Proximal Component, Additional Segmen

K110940510(k) TraditionalCleared Jul 1, 201188-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 Jul 1, 2011 as substantially equivalent to K070978 (Zimmer, Inc., 2007) and 3 other predicates after an 88-day review. Its family tree reaches back 3 generations to 1996. 10 later devices descend from it.

Decided: Jul 1, 2011
Review: 88 days
Class: Class II
Product code: KRO
Recalls: None
Predicates: 5

Its longest line of descent runs back 3 generations to K945028 (1996). 6 ancestors in all. 10 later devices descend from it, 5 citing it directly.

By dateBy generation

Root · 3 generations backK945028 Finn Knee SystemBiomet, Inc. · 1996
2 generations backK013385 Nexgen Complete Knee Solution Rotatng Hinge KneeZimmer, Inc. · 2002 · Recalled
1 generation backK070978 Zimmer Segmental SystemZimmer, Inc. · 2007 · Recalled
This deviceK110940 Zimmer Segment System Trabecular Metal Proximal Tibial Component…Zimmer, Inc. · 2011
Descendant · cites it directly · 3 of its ownK141331 Biomet Orthopaedic Salvage System (Oss)Biomet, Inc. · 2014
Descendant · cites it directly · 2 of its ownK190100 USTAR II SystemUnited Orthopedic Corporation · 2019 · Recalled
Descendant · cites it directly · 1 of its ownK183136 Zimmer Segmental System Proximal Femoral ComponentZimmer, Inc. · 2019
Descendant · 2 generations on · 1 of its ownK142814 Biomet Orthopaedic Salvage System (OSSTM) - Proximal Femoral &…Biomet Manufacturing, LLC · 2015 · Recalled
Descendant · 2 generations on · 0 of its ownK253515 Zimmer Biomet OSS™ Orthopedic Salvage System OsseoTi® Sleeves and…Biomet Orthopedics, Inc. · 2026

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2014high 3 (2025) · low 0 (2016)2026

Most influential descendants

Showing 5 of 10 · See all

K141331Biomet Orthopaedic Salvage System (Oss)Biomet, Inc. · 2014 · cites it directly3descendants
K190100USTAR II SystemUnited Orthopedic Corporation · 2019 · cites it directly2descendants
K183136Zimmer Segmental System Proximal Femoral ComponentZimmer, Inc. · 2019 · cites it directly1descendant
K142814Biomet Orthopaedic Salvage System (OSSTM) - Proximal Femoral & Hybrid TibialBiomet Manufacturing, LLC · 2015 · 2 generations on1descendant
K253515Zimmer Biomet OSS™ Orthopedic Salvage System OsseoTi® Sleeves and AugmentsBiomet Orthopedics, Inc. · 2026 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K945028	Finn Knee System	Biomet, Inc.	1996	—
−2	K013385	Nexgen Complete Knee Solution Rotatng Hinge Knee	Zimmer, Inc.	2002	2
−1	K070978	Zimmer Segmental System	Zimmer, Inc.	2007	6
0 (this device)	K110940	Zimmer Segment System Trabecular Metal Proximal Tibial Component, Trabecular…	Zimmer, Inc.	2011	—
+1	K141331	Biomet Orthopaedic Salvage System (Oss)	Biomet, Inc.	2014	—
+1	K190100	USTAR II System	United Orthopedic Corporation	2019	5
+1	K183136	Zimmer Segmental System Proximal Femoral Component	Zimmer, Inc.	2019	—
+2	K142814	Biomet Orthopaedic Salvage System (OSSTM) - Proximal Femoral & Hybrid Tibial	Biomet Manufacturing, LLC	2015	6
+2	K253515	Zimmer Biomet OSS™ Orthopedic Salvage System OsseoTi® Sleeves and Augments	Biomet Orthopedics, Inc.	2026	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1997	1	0
2000	1	0
2010	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2014	1	0
2015	2	0
2019	2	0
2020	1	0
2025	3	0
2026	1	0

FIG. 1 — Lineage of K110940, 1996–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 K251665 Triathlon® Hinge Knee Systemscore 19.0 · 12 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

Type	Number	Device	Applicant	Decided	Recalls
*	K070978	Zimmer Segmental System Summary page 2 …Cemented, Metal/Polymer; 21 CFR § 888.3510 Predicate Devices: Zimmer Segmental System, manufactured by Zimmer Inc. (K070978, cleared July 3, 2007) Zimmer Segmental System Proximal Femoral Component, manuf…	Zimmer, Inc.	2007	6
*	K101296	Zimmer Segmental System Proximal Femoral Component and Small Diameter Stem Extensions Summary page 2 …d July 3, 2007) Zimmer Segmental System Proximal Femoral Component, manufactured by Zimmer Inc. (K 101296, cleared July 30, 2010) MOST System, manufactured Intermedics Orthopedics, Inc.…	Zimmer, Inc.	2010	2
*	K964350	Modula Options for Severe Bone Loss and Trauma Summary page 2 …Inc. (K 101296, cleared July 30, 2010) MOST System, manufactured Intermedics Orthopedics, Inc. (K9643 50, cleared January 16, 1997) MOST Options System, manufactured Sulzer…	Intermedics Orthopedics	1997	—
Kept off the family tree	K001303	FDA’s K001303 is Breast Immobilization Device MR-by 160 Our reading of the summary gave K001303, FDA’s number for Breast Immobilization Device MR-by 160 (Mri Devices Corp.). Its FDA name has none of the distinctive words the summary uses for the device it names, “MOST Options System”. Kept off the family tree.	Mri Devices Corp.	2000	—
*	K013385	Nexgen Complete Knee Solution Rotatng Hinge Knee Summary page 2 …200 1) NexGen® Complete Knee Solutions Rotating Hinge Knee System, manufactured by Zimmer, Inc. (K013385, cleared January 9, 2002) Device Description: The Zimmier Segmental System is intended to replace th…	Zimmer, Inc.	2002	2

Also cleared against K070978: 4 other devices →

What descends from it? (10)

5 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K141331	Biomet Orthopaedic Salvage System (Oss)	Biomet, Inc.	2014	3
K190100	USTAR II System	United Orthopedic Corporation	2019	2
K183136	Zimmer Segmental System Proximal Femoral Component	Zimmer, Inc.	2019	1
K241059	Pantheon Proximal Femur Reconstruction (PFR) System	Adler Ortho S.P.A	2025	0
K192798	Zimmer Segmental System	Zimmer, Inc.	2020	0

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 15 years and passes through 2 companies; a new generation was cleared every 5.5 years on median.
4 of the 6 ancestors have a recall of any class.
Of its descendants, K141331 (Biomet, Inc., 2014) has gone furthest, with 3 descendants of its own.
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. 2011, this device’s year, is highlighted.

FDA decisions per year · KRO

3in 2025

2007high 6 (2015) · low 0 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KRO

56in 2025

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

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

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

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	1	—	1	37
2008	3	126	3	44
2009	3	86	8	66
2010	1	—	0	110
2011	2	—	1	119
2012	2	—	1	173
2013	3	189	2	194
2014	2	—	0	406
2015	6	113	1	333
2016	3	148	5	369
2017	1	—	4	543
2018	0	—	1	614
2019	3	244	0	759
2020	1	—	0	749
2021	3	57	1	770
2022	1	—	0	892
2023	4	148	0	746
2024	3	87	0	855
2025	3	56	1	915
2026	1	—	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, osteoarthritis, traumatic arthritis, polyartliritis, collagen disorders, and/or avascular necrosis of the proximal and/or distal femur and/or proximal tibia. - Valgus, yamus or flexion deformities - The salvage of previously failed surgical attempts A total femoral replacement…

Read the full statement (197 words)

This device is indicated for:

- Moderate to severe knee instability

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

- Valgus, yamus or flexion deformities

- The salvage of previously failed surgical attempts

A total femoral replacement construct consisting of the MOST Options@ or Segmental proximal femoral, 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 TrabecularMetal 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 TrabecularMetal 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 TrabecularMetal 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.

https://510kreport.com/device/K110940 · printed Nov 6, 2026

Cite this page

510(k) Report. “K110940: Zimmer Segment System Trabecular Metal Proximal Tibial Component, Trabecular Metal Proximal Component, Additional Segmen.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110940

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)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026