510(k) · Cleared
ClearedMP Reconstruction System
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 Apr 11, 2022 as substantially equivalent to K142187 (Waldemar Link GmbH & Co. KG, 2014) and 1 other predicate after a 140-day review. Its family tree reaches back 2 generations to 1996.
- Decided
- Apr 11, 2022
- Review
- 140 days
- Class
- Class II
- Product code
- LZO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K955296 (1996). 4 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K955296 | Link MP Reconstruction Hip | Link America, Inc. | 1996 | 21 |
| −1 | K142187 | Link MP Reconstruction Prosthesis | Waldemar Link GmbH & Co. KG | 2014 | 2 |
| 0 (this device) | K213675 | MP Reconstruction System | Waldemar Link GmbH & Co. KG | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2015 | 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? (2)
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 |
|---|---|---|---|
| * | K142187 | Link MP Reconstruction ProsthesisSummary page 4…prosthesis; 21 CFR §888.3350, product code JDI Classification and Panel: Class II, Orthopedic / 87 Predicate Devices: LINK MP Reconstruction Hip (K142187) – Primary Predicate LINK MEGASYSTEM-C (K151008) Device Description:… | 2014 |
| * | K151008 | Link® Megasystem-C®Summary page 4…dic / 87 Predicate Devices: LINK MP Reconstruction Hip (K142187) – Primary Predicate LINK MEGASYSTEM-C (K151008) Device Description: This 510k adds Cemented Stems to the MP Reconstructio… | 2015 |
What descends from it?
No later submission names this one as a predicate yet.
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 26 years and passes through 2 companies; a new generation was cleared every 18.7 years on median.
- 4 of the 4 ancestors have a recall of any class.
- 1 other device also cites its predicate K142187.
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. 2022, 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 MP Reconstruction System 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 MP Reconstruction System is indicated for the following conditions: 1. Revision arthroplasty due to juxta-articular bone defects. 2. Revision of loosened femoral prosthesis components involving…
Read the full statement (141 words)
The MP Reconstruction System 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 MP Reconstruction System 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 MP Reconstruction System is for cementless use. Only cemented labeled modular stems are indicated for cemented
use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K213675 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213675: MP Reconstruction System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K213675
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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