510(k) · Cleared
ClearedZimmer Segmental System XT Components
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 Feb 6, 2015 as substantially equivalent to K070978 (Zimmer, Inc., 2007) after a 30-day review. Its family tree reaches back 3 generations to 1996. 1 later device descends from it.
- Decided
- Feb 6, 2015
- Review
- 30 days
- Class
- Class II
- Product code
- KRO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K945028 (1996). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- 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 deviceK150028 Zimmer Segmental System XT ComponentsZimmer, Inc. · 2015
- Descendant · cites it directly · 0 of its ownK192798 Zimmer Segmental SystemZimmer, Inc. · 2020
Most influential descendants
Showing 1 of 1 · See all- K192798Zimmer Segmental SystemZimmer, Inc. · 2020 · cites it directly0descendants
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) | K150028 | Zimmer Segmental System XT Components | Zimmer, Inc. | 2015 | — |
| +1 | K192798 | Zimmer Segmental System | Zimmer, Inc. | 2020 | — |
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 |
|---|---|---|
| 2020 | 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? (1)
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 |
|---|---|---|---|
| * | K070978 | Zimmer Segmental SystemSummary page 4…constrained cemented prosthesis Predicate Device: Zimmer Segmental System, manufactured by Zimmer, Inc., K070978, cleared July 3, 2007 Device Description / Intended Use: The Zimmer Segmental System is intended to… | 2007 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K192798 | Zimmer Segmental System | 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 19 years and passes through 2 companies; a new generation was cleared every 5.9 years on median.
- 3 of the 4 ancestors have a recall of any class.
- Of its descendants, K192798 (Zimmer, Inc., 2020) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K070978.
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. 2015, 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 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 (205 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 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 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 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.
https://510kreport.com/device/K150028 · printed Nov 4, 2026
Cite this page
510(k) Report. “K150028: Zimmer Segmental System XT Components.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K150028
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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