510(k) · Cleared
Recalled · Class II · 2017Zimmer Segmental System Variable Stiffness Stem Extensions and Intercalary Segments
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zimmer, Inc. · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Cleared on Sep 26, 2008 as substantially equivalent to K070978 (Zimmer, Inc., 2007) and 3 other predicates after an 87-day review. Its family tree reaches back 3 generations to 1996. 1 later device descends from it. It has been recalled once.
- Decided
- Sep 26, 2008
- Review
- 87 days
- Class
- Class II
- Product code
- LZO
- Recalls
- 1
- Predicates
- 4
Its longest line of descent runs back 3 generations to K945028 (1996). 14 ancestors in all, the oldest K870730 (1987). 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 deviceK081860 Zimmer Segmental System Variable Stiffness Stem Extensions and…Zimmer, Inc. · 2008
- 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) | K081860 | Zimmer Segmental System Variable Stiffness Stem Extensions and Intercalary… | Zimmer, Inc. | 2008 | — |
| +1 | K192798 | Zimmer Segmental System | Zimmer, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 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 LZO? 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 LZO device
- #1 K192827 Quadra-Pscore 19.3 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 1…21 CFR § 888.3353 Predicate Devices: Zimmer Segmental System, manufactured by Zimmer, Inc. (K070978, cleared July 03, 2007); MOST System, manufactured by Intermedics… | 2007 |
| * | K960626 | Modular Oncology System Technology (Most)Summary page 1…978, cleared July 03, 2007); MOST System, manufactured by Intermedics Orthopedics, Inc. (K960626, cleared April 18, 1996 and K973087, cleared November 14, 1997);… | 1996 |
| * | K973087 | Most Hex Intramedullary (I/M) StemSummary page 1…ystem, manufactured by Intermedics Orthopedics, Inc. (K960626, cleared April 18, 1996 and K973087, cleared November 14, 1997); Orthogenesis LPS System Intercalary,… | 1997 |
| * | K003182 | Orthogenesis LPS SystemSummary page 1…ed November 14, 1997); Orthogenesis LPS System Intercalary, manufactured by DePuy, Inc. (K003182, cleared June 27, 2001) Device Description: The Variable Stiffness S… | 2001 |
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 28, 2017 | Class II | Z-2576-2017 | 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. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 2 companies; a new generation was cleared every 5.5 years on median.
- 4 of the 14 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 LZO devicesLZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · LZO
14in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LZO
119in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LZO
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LZO
3,244in 2025
MAUDE reports naming product code LZO, 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 | 9 | 87 | 2 | 138 |
| 2008 | 11 | 63 | 13 | 125 |
| 2009 | 7 | 83 | 42 | 189 |
| 2010 | 15 | 78 | 0 | 394 |
| 2011 | 13 | 87 | 10 | 544 |
| 2012 | 14 | 98 | 14 | 963 |
| 2013 | 26 | 100 | 0 | 1,370 |
| 2014 | 13 | 85 | 1 | 1,477 |
| 2015 | 12 | 115 | 1 | 1,348 |
| 2016 | 10 | 177 | 9 | 1,728 |
| 2017 | 16 | 257 | 5 | 2,165 |
| 2018 | 18 | 163 | 2 | 3,133 |
| 2019 | 28 | 109 | 4 | 3,066 |
| 2020 | 18 | 112 | 3 | 1,963 |
| 2021 | 12 | 170 | 0 | 2,199 |
| 2022 | 11 | 279 | 4 | 1,985 |
| 2023 | 10 | 122 | 2 | 2,066 |
| 2024 | 11 | 111 | 1 | 2,586 |
| 2025 | 14 | 119 | 1 | 3,244 |
| 2026 | 9 | 102 | 0 | — |
What is it indicated for?
General Indications for the Segmental System: * 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 Indications specific to…
Read the full statement (112 words)
General Indications for the Segmental System:
* 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
Indications specific to the Variable Stiffness Stem extensions:
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, but the remainder of the stem must be used uncemented.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081860 · printed Nov 5, 2026
Cite this page
510(k) Report. “K081860: Zimmer Segmental System Variable Stiffness Stem Extensions and Intercalary Segments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K081860
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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