510(k) · Cleared
Recalled · Class II · 2014Most Options System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sulzer Orthopedics, Inc. · KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
Cleared on Dec 7, 2001 after an 88-day review. The FDA summary names its predicate without a number. 6 later devices descend from it. It has been recalled 3 times.
- Decided
- Dec 7, 2001
- Review
- 88 days
- Class
- Class II
- Product code
- KRO
- Recalls
- 3
- Predicates
- 0
6 later devices descend from it, 3 citing it directly.
- This deviceK013031 Most Options SystemSulzer Orthopedics, Inc. · 2001
- Descendant · cites it directly · 5 of its ownK173057 Zimmer Knee Joint Replacement Prostheses MR LabelingZimmer, Inc. · 2018 · Recalled
- Descendant · cites it directly · 4 of its ownK181947 Persona Revision Knee SystemZimmer, Inc. · 2018 · Recalled
- Descendant · cites it directly · 1 of its ownK191625 Persona Revision Knee SystemZimmer, Inc. · 2019 · Recalled
- Descendant · 2 generations on · 0 of its ownK243724 Persona® Revision Knee System (Persona Revision SoluTion™ Femoral…Zimmer, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK210829 Persona Revision Knee System Femoral Metaphyseal ConesZimmer, Inc. · 2021
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K173057Zimmer Knee Joint Replacement Prostheses MR LabelingZimmer, Inc. · 2018 · cites it directly5descendants
- K181947Persona Revision Knee SystemZimmer, Inc. · 2018 · cites it directly4descendants
- K191625Persona Revision Knee SystemZimmer, Inc. · 2019 · cites it directly1descendant
- K243724Persona® Revision Knee System (Persona Revision SoluTion™ Femoral Components)Zimmer, Inc. · 2025 · 2 generations on0descendants
- K210829Persona Revision Knee System Femoral Metaphyseal ConesZimmer, Inc. · 2021 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K013031 | Most Options System | Sulzer Orthopedics, Inc. | 2001 | — |
| +1 | K173057 | Zimmer Knee Joint Replacement Prostheses MR Labeling | Zimmer, Inc. | 2018 | 2 |
| +1 | K181947 | Persona Revision Knee System | Zimmer, Inc. | 2018 | 1 |
| +1 | K191625 | Persona Revision Knee System | Zimmer, Inc. | 2019 | 1 |
| +2 | K243724 | Persona® Revision Knee System (Persona Revision SoluTion™ Femoral Components) | Zimmer, Inc. | 2025 | — |
| +2 | K210829 | Persona Revision Knee System Femoral Metaphyseal Cones | Zimmer, Inc. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2021 | 2 | 0 |
| 2025 | 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? (3)
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 |
|---|---|---|---|
| * | — | Sulzer Orthopedics MOST™ System Named without a submission number | |
| * | — | Johnson & Johnson S-ROM® Noiles™ Rotating Hinge Knee System Named without a submission number | |
| * | — | Howmedica Osteonics® Modular Rotating Hinge Knee (MRS) Named without a submission number |
What descends from it? (6)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 25, 2014 | Class II | Z-1250-2014 | Storage | A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the discoloration was the result of free radical oxidation. The oxidation process was advanced prematurely as a result of the machined component… |
| Jan 29, 2009 | Not classified | Z-0996-2009 | Packaging process control | The package contains 11 mm screws instead of the specified 6 mm screws. |
| Dec 17, 2004 | Not classified | Z-0539-05 | Other | Risk of adapter disassociation from mating components when assembled improperly or when subjected to high-stress femoral applications. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K173057 (Zimmer, Inc., 2018) has gone furthest, with 5 descendants of its own.
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.
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?
The MOST System is intended to replace the proximal, distal or total femur and/or the proximal tibia, especially in cases that require extensive resection and restoration. Replacement of the distal femur would also include replacement of the proximal tibia and possible resurfacing of the patella, if necessary. Proximal femoral replacement components are available for press-fit or cemented applications. Components used for replacement of the distal femur…
Read the full statement (161 words)
The MOST System is intended to replace the proximal, distal or total femur and/or
the proximal tibia, especially in cases that require extensive resection and
restoration. Replacement of the distal femur would also include replacement of the
proximal tibia and possible resurfacing of the patella, if necessary. Proximal femoral
replacement components are available for press-fit or cemented applications.
Components used for replacement of the distal femur and proximal tibia are
intended for cemented use only. Specific diagnostic indications for use of the MOST
include:
1. metastatic diseases (e.g., osteosarcomas, chondrosarcomas, giant cell tumors,
bone tumors ) requiring extensive resection(s) and replacement(s) of the
proximal and/or distal femur and/or proximal tibia;
2. patient conditions of non-inflammatory degenerative joint disease (NIDJD),
e.g., avascular necrosis, osteoarthritis and inflammatory (1JD), e.g. rheumatoid
arthritis, requiring extensive resection(s) and replacement(s) of the proximal
and/or distal femur and/or proximal tibia; and
3. revision cases requiring resection(s) and replacement(s) of the proximal, distal
or total femur and/or proximal tibia.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K013031 · printed Nov 5, 2026
Cite this page
510(k) Report. “K013031: Most Options System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K013031
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026