510(k) · Cleared
Recalled · Class II · 2023LINK MP Monoblock Hip Prosthesis
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Waldemar Link GmbH & Co. KG · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Cleared on Feb 8, 2019 as substantially equivalent to K973837 (Sulzer Orthopedics, Inc., 1998) after an 87-day review. Its family tree reaches back 1 generation to 1998. 1 later device descends from it. It has been recalled 12 times.
- Decided
- Feb 8, 2019
- Review
- 87 days
- Class
- Class II
- Product code
- LZO
- Recalls
- 12
- Predicates
- 1
Its longest line of descent runs back 1 generation to K973837 (1998). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK973837 CLS Stem, Wagner Revision Stem, Alloclassic Zweymuller Stem, SLSulzer Orthopedics, Inc. · 1998
- This deviceK183141 LINK MP Monoblock Hip ProsthesisWaldemar Link GmbH & Co. KG · 2019
- Descendant · cites it directly · 0 of its ownK260173 M-Vizion Femoral Revision System ExtensionMedacta International S.A. · 2026
Most influential descendants
Showing 1 of 1 · See all- K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K973837 | CLS Stem, Wagner Revision Stem, Alloclassic Zweymuller Stem, SL | Sulzer Orthopedics, Inc. | 1998 | — |
| 0 (this device) | K183141 | LINK MP Monoblock Hip Prosthesis | Waldemar Link GmbH & Co. KG | 2019 | — |
| +1 | K260173 | M-Vizion Femoral Revision System Extension | Medacta International S.A. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 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? (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 |
|---|---|---|---|
| * | K973837 | CLS Stem, Wagner Revision Stem, Alloclassic Zweymuller Stem, SLSummary page 4…sis. Product Code LZO Classification Class II, Orthopedic / 87 and Panel: Predicate Wagner SL Revision Stem by Zimmer Biomet Holding, Inc., Devices: K973837, cleared January 6, 1998 Reference LINK® MP® Reconstruction Prostheses by Waldemar Link GmbH & Device: Co. KG, K1… | 1998 |
| † | K142187 | Link MP Reconstruction Prosthesis | 2014 |
| † | K161840 | LINK® SP-CL® Hip System PoroLink® (microporous) and HX® (CaP) coated & LINK® LCU® Hip… | 2017 |
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 |
|---|---|---|---|
| K260173 | M-Vizion Femoral Revision System Extension | 2026 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 3, 2023 | Class II | Z-2354-2023 | Device Design | Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm - 25mm),after impaction. Potential for prolongation of surgery or the surgical procedure may have to be modified due to this issue |
| Jul 3, 2023 | Class II | Z-2346-2023 | Device Design | Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm - 25mm),after impaction. Potential for prolongation of surgery or the surgical procedure may have to be modified due to this issue |
| Jul 3, 2023 | Class II | Z-2349-2023 | Device Design | Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm - 25mm),after impaction. Potential for prolongation of surgery or the surgical procedure may have to be modified due to this issue |
| Jul 3, 2023 | Class II | Z-2348-2023 | Device Design | Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm - 25mm),after impaction. Potential for prolongation of surgery or the surgical procedure may have to be modified due to this issue |
| Jul 3, 2023 | Class II | Z-2350-2023 | Device Design | Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm - 25mm),after impaction. Potential for prolongation of surgery or the surgical procedure may have to be modified due to this issue |
| Jul 3, 2023 | Class II | Z-2347-2023 | Device Design | Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm - 25mm),after impaction. Potential for prolongation of surgery or the surgical procedure may have to be modified due to this issue |
| Jul 3, 2023 | Class II | Z-2356-2023 | Device Design | Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm - 25mm),after impaction. Potential for prolongation of surgery or the surgical procedure may have to be modified due to this issue |
| Jul 3, 2023 | Class II | Z-2353-2023 | Device Design | Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm - 25mm),after impaction. Potential for prolongation of surgery or the surgical procedure may have to be modified due to this issue |
| Jul 3, 2023 | Class II | Z-2352-2023 | Device Design | Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm - 25mm),after impaction. Potential for prolongation of surgery or the surgical procedure may have to be modified due to this issue |
| Jul 3, 2023 | Class II | Z-2345-2023 | Device Design | Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm - 25mm),after impaction. Potential for prolongation of surgery or the surgical procedure may have to be modified due to this issue |
| Jul 3, 2023 | Class II | Z-2351-2023 | Device Design | Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm - 25mm),after impaction. Potential for prolongation of surgery or the surgical procedure may have to be modified due to this issue |
| Jul 3, 2023 | Class II | Z-2355-2023 | Device Design | Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm - 25mm),after impaction. Potential for prolongation of surgery or the surgical procedure may have to be modified due to this issue |
The 5 latest of 12 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K260173 (Medacta International S.A., 2026) has gone furthest, with 0 descendants of its own.
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. 2019, 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?
The LINK® MP® Monoblock is indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur which cannot be treated by conservative or osteosynthetic procedures
The LINK® MP® Monoblock is indicated for the following conditions:
- Revision of loosened femoral prosthesis components involving extensive bone resorption of the proximal femur and widening of the medullary cavity or marked thinning of proximal femoral cortical bone the fixation of a new standard prosthesis is not possible
- Revision of loosened femoral prosthesis components by peri-/subprosthetic fracture
The device is intended for cementless use.
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/K183141 · printed Nov 6, 2026
Cite this page
510(k) Report. “K183141: LINK MP Monoblock Hip Prosthesis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K183141
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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