510(k) · Cleared
Recalled · Class II · 2017Zimmer Segmental System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zimmer, Inc. · KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
Cleared on Jul 3, 2007 as substantially equivalent to K013385 (Zimmer, Inc., 2002) and 1 other predicate after an 88-day review. Its family tree reaches back 2 generations to 1996. 13 later devices descend from it. It has been recalled 6 times.
- Decided
- Jul 3, 2007
- Review
- 88 days
- Class
- Class II
- Product code
- KRO
- Recalls
- 6
- Predicates
- 2
Its longest line of descent runs back 2 generations to K945028 (1996). 3 ancestors in all. 13 later devices descend from it, 5 citing it directly.
- Root · 2 generations backK945028 Finn Knee SystemBiomet, Inc. · 1996
- 1 generation backK013385 Nexgen Complete Knee Solution Rotatng Hinge KneeZimmer, Inc. · 2002 · Recalled
- This deviceK070978 Zimmer Segmental SystemZimmer, Inc. · 2007
- Descendant · cites it directly · 10 of its ownK110940 Zimmer Segment System Trabecular Metal Proximal Tibial Component…Zimmer, Inc. · 2011
- Descendant · 2 generations on · 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 · 2 generations on · 1 of its ownK183136 Zimmer Segmental System Proximal Femoral ComponentZimmer, Inc. · 2019
- Descendant · 3 generations on · 1 of its ownK142814 Biomet Orthopaedic Salvage System (OSSTM) - Proximal Femoral &…Biomet Manufacturing, LLC · 2015 · Recalled
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K110940Zimmer Segment System Trabecular Metal Proximal Tibial Component, Trabecular Metal…Zimmer, Inc. · 2011 · cites it directly10descendants
- K141331Biomet Orthopaedic Salvage System (Oss)Biomet, Inc. · 2014 · 2 generations on3descendants
- K190100USTAR II SystemUnited Orthopedic Corporation · 2019 · cites it directly2descendants
- K183136Zimmer Segmental System Proximal Femoral ComponentZimmer, Inc. · 2019 · 2 generations on1descendant
- K142814Biomet Orthopaedic Salvage System (OSSTM) - Proximal Femoral & Hybrid TibialBiomet Manufacturing, LLC · 2015 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K945028 | Finn Knee System | Biomet, Inc. | 1996 | — |
| −1 | K013385 | Nexgen Complete Knee Solution Rotatng Hinge Knee | Zimmer, Inc. | 2002 | 2 |
| 0 (this device) | K070978 | Zimmer Segmental System | Zimmer, Inc. | 2007 | — |
| +1 | K110940 | Zimmer Segment System Trabecular Metal Proximal Tibial Component, Trabecular… | Zimmer, Inc. | 2011 | — |
| +2 | K141331 | Biomet Orthopaedic Salvage System (Oss) | Biomet, Inc. | 2014 | — |
| +1 | K190100 | USTAR II System | United Orthopedic Corporation | 2019 | 5 |
| +2 | K183136 | Zimmer Segmental System Proximal Femoral Component | Zimmer, Inc. | 2019 | — |
| +3 | K142814 | Biomet Orthopaedic Salvage System (OSSTM) - Proximal Femoral & Hybrid Tibial | Biomet Manufacturing, LLC | 2015 | 6 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 3 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2025 | 3 | 0 |
| 2026 | 1 | 0 |
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
What was it cleared against? (2)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K013385 | Nexgen Complete Knee Solution Rotatng Hinge KneeSummary page 1…NexGen® Complete Knee Solutions Rotating Hinge Knee Systems, manufactured by Zimmer, Inc., K013385, cleared January 9, 2002. Modular Options for Severe Bone Loss and Trauma… | 2002 |
| * | K002324 | Modified to Modular FR Severe Bone Loss TraumaSummary page 1…Modular Options for Severe Bone Loss and Trauma (MOST®) System, manufactured by Zimmer Inc., K002324, cleared August 24, 2000. Device Description: The Zimmer®Segmental System is a fully… | 2000 |
What descends from it? (13)
See all 135 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K110940 | Zimmer Segment System Trabecular Metal Proximal Tibial Component, Trabecular Metal… | 2011 | 10 |
| K190100 | USTAR II System | 2019 | 2 |
| K150028 | Zimmer Segmental System XT Components | 2015 | 1 |
| K081860 | Zimmer Segmental System Variable Stiffness Stem Extensions and Intercalary Segments | 2008 | 1 |
| K192798 | Zimmer Segmental System | 2020 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 1, 2017 | Class II | Z-0721-2018 | Package design/selection | The products being recalled exceeded the weight previously tested leading to a possibility of damage to the package and/or a compromised sterile barrier. |
| Feb 28, 2017 | Class II | Z-2566-2017 | Packaging | Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures. |
| Feb 28, 2017 | Class II | Z-2574-2017 | Packaging | Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures. |
| Feb 28, 2017 | Class II | Z-2575-2017 | Packaging | Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures. |
| Dec 19, 2013 | Class II | Z-0783-2014 | Device Design | After evaluation of 13 complaints(0.4% rate) for hyper-extension of the Zimmer Segmental System, Zimmer is updating the related surgical technique and instructions for use to provide additional instructions and patient conditions that may… |
| Dec 19, 2013 | Class II | Z-0784-2014 | Device Design | After evaluation of 13 complaints(0.4% rate) for hyper-extension of the Zimmer Segmental System, Zimmer is updating the related surgical technique and instructions for use to provide additional instructions and patient conditions that may… |
The 5 latest of 6 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 11 years and passes through 2 companies; a new generation was cleared every 5.9 years on median.
- 2 of the 3 ancestors have a recall of any class.
- Of its descendants, K110940 (Zimmer, Inc., 2011) has gone furthest, with 10 descendants of its own.
- 8 other devices also cite its predicate K013385.
How does its category compare?
All KRO devicesKRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · KRO
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KRO
56in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KRO
14so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KRO
915in 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, polyarthritis, collagen disorders, and/or avascular necrosis of the femoral condyle - Valgus, varus or flexion deformities - The salvage of previously failed surgical attempts A total femoral replacement construct consisting of MOST Options proximal…
Read the full statement (153 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, polyarthritis, collagen disorders, and/or avascular necrosis of the femoral condyle
- Valgus, varus or flexion deformities
- The salvage of previously failed surgical attempts
A total femoral replacement construct consisting of MOST Options proximal femoral, Segmental System segments and Segmental System distal femoral components may be used without cement.
* 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 and the remainder of the stem must also be cemented against the bone.
* The TrabecularMetal collar may be used cemented or uncemented against the bone as long as the remainder of the stem extension is cemented.
* All other constructs are for cemented use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070978 · printed Nov 4, 2026
Cite this page
510(k) Report. “K070978: Zimmer Segmental System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K070978
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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