510(k) · Cleared
Recalled · Class II · 2024Link MP Reconstruction 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 Nov 6, 2014 as substantially equivalent to K955296 (Link America, Inc., 1996) after a 90-day review. Its family tree reaches back 1 generation to 1996. 2 later devices descend from it. It has been recalled 2 times.
- Decided
- Nov 6, 2014
- Review
- 90 days
- Class
- Class II
- Product code
- LZO
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 1 generation to K955296 (1996). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK955296 Link MP Reconstruction HipLink America, Inc. · 1996 · Recalled
- This deviceK142187 Link MP Reconstruction ProsthesisWaldemar Link GmbH & Co. KG · 2014
- Descendant · cites it directly · 0 of its ownK213675 MP Reconstruction SystemWaldemar Link GmbH & Co. KG · 2022
- Descendant · cites it directly · 0 of its ownK190181 Instruments for LINK MEGASYSTEM-C FamilyLinkBio Corp. · 2019
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K955296 | Link MP Reconstruction Hip | Link America, Inc. | 1996 | 21 |
| 0 (this device) | K142187 | Link MP Reconstruction Prosthesis | Waldemar Link GmbH & Co. KG | 2014 | — |
| +1 | K213675 | MP Reconstruction System | Waldemar Link GmbH & Co. KG | 2022 | — |
| +1 | K190181 | Instruments for LINK MEGASYSTEM-C Family | LinkBio Corp. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2022 | 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 |
|---|---|---|---|
| * | K955296 | Link MP Reconstruction HipSummary page 4…§888.3353, product code LZO Classification and Panel: Class II, Orthopedic / 87 Predicate Devices: LINK® MP® Reconstruction Hip (K955296) Device Description: The LINK® MP® Reconstruction Prosthesis modular system consists of Pros… | 1996 |
What descends from it? (2)
2 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 |
|---|---|---|---|---|
| Dec 5, 2024 | Class II | Z-0769-2025 | Under Investigation by firm | Error on the main label and the patient label. The labels indicate a size XXL, this is a standard-size neck segment.. All further information on the labels is correct (Length, CCD and Offset). |
| Dec 7, 2018 | Class II | Z-0733-2019 | Under Investigation by firm | The reaming guide and the guide rod can't be screwed into the intended depth. The reason for this is a reduced depth of the core hole in the stem. A reaming guide that is not screwed in completely may lead to a proximal preparation in the… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
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. 2014, 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® Reconstruction Prosthesis is intended for revision hip arthroplasty in patients whose bone stock is of poor quality or inadequate for other reconstruction techniques as indicated by deficiencies of the femoral head, neck, or portions of the proximal femur. The LINK® MP® Reconstruction Hip Prosthesis is indicated for the following conditions: 1) Revision arthroplasty due to juxta-articular bone defects. 2) Revision of loosened femoral…
Read the full statement (138 words)
The LINK® MP® Reconstruction Prosthesis is intended for revision hip arthroplasty in patients whose bone stock is of poor quality or inadequate for other reconstruction techniques as indicated by deficiencies of the femoral head, neck, or portions of the proximal femur. The LINK® MP® Reconstruction Hip Prosthesis is indicated for the following conditions:
1) Revision arthroplasty due to juxta-articular bone defects.
2) 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.
3) Revision of loosened femoral prosthesis components by peri- / subprosthetic fracture.
4) Deformed proximal femur due to fractures or osteotomies.
5) Correction of bone deficiencies, e.g. due to tumors.
6) Large post-revision and post-trauma segmental bone defects.
The LINK® MP® Reconstruction Prosthesis is for cementless use only.
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/K142187 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142187: Link MP Reconstruction Prosthesis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142187
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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