510(k) · Cleared
Recalled · Class II · 2012Medacta Total Hip Prosthesis System - Quadra C
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medacta International S.A. · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Cleared on Mar 6, 2009 as substantially equivalent to K072857 (Medacta International S.A., 2008) and 2 other predicates after a 94-day review. Its family tree reaches back 4 generations to 1994. 9 later devices descend from it. It has been recalled once.
- Decided
- Mar 6, 2009
- Review
- 94 days
- Class
- Class II
- Product code
- LZO
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 4 generations to K932481 (1994). 8 ancestors in all. 9 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK932481 SL-Plus and SLR-PlusEncore Orthopedics, Inc. · 1994
- 3 generations backK001942 SL-Plus and SLR-Plus StemsPlus Orthopedics · 2000
- 2 generations backK021178 SL-Plus Lateralized StemPlus Orthopedics · 2002
- 1 generation backK072857 Total Hip Prosthesis System Quadra S + Cocrmo Femoral Ball Head +…Medacta International S.A. · 2008 · Recalled
- This deviceK083558 Medacta Total Hip Prosthesis System - Quadra CMedacta International S.A. · 2009
- Descendant · cites it directly · 6 of its ownK192827 Quadra-PMedacta International S.A. · 2020
- Descendant · 2 generations on · 1 of its ownK202730 Quadra-PMedacta International S.A. · 2020
- Descendant · 2 generations on · 1 of its ownK203041 SMS Cementless StemMedacta International S.A. · 2020
- Descendant · cites it directly · 1 of its ownK103189 Medacta Total Hip Prosthesis System - Amistem C & Quadra C Short NeckMedacta International S.A. · 2010 · Recalled
- Descendant · 2 generations on · 0 of its ownK250450 Coated hip implantsMedacta International S.A. · 2025
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K192827Quadra-PMedacta International S.A. · 2020 · cites it directly6descendants
- K202730Quadra-PMedacta International S.A. · 2020 · 2 generations on1descendant
- K203041SMS Cementless StemMedacta International S.A. · 2020 · 2 generations on1descendant
- K103189Medacta Total Hip Prosthesis System - Amistem C & Quadra C Short NeckMedacta International S.A. · 2010 · cites it directly1descendant
- K250450Coated hip implantsMedacta International S.A. · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K932481 | SL-Plus and SLR-Plus | Encore Orthopedics, Inc. | 1994 | — |
| −3 | K001942 | SL-Plus and SLR-Plus Stems | Plus Orthopedics | 2000 | — |
| −2 | K021178 | SL-Plus Lateralized Stem | Plus Orthopedics | 2002 | — |
| −1 | K072857 | Total Hip Prosthesis System Quadra S + Cocrmo Femoral Ball Head + Apricot | Medacta International S.A. | 2008 | 1 |
| 0 (this device) | K083558 | Medacta Total Hip Prosthesis System - Quadra C | Medacta International S.A. | 2009 | — |
| +1 | K192827 | Quadra-P | Medacta International S.A. | 2020 | — |
| +2 | K202730 | Quadra-P | Medacta International S.A. | 2020 | — |
| +2 | K203041 | SMS Cementless Stem | Medacta International S.A. | 2020 | — |
| +1 | K103189 | Medacta Total Hip Prosthesis System - Amistem C & Quadra C Short Neck | Medacta International S.A. | 2010 | 1 |
| +2 | K250450 | Coated hip implants | Medacta International S.A. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2020 | 4 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2025 | 2 | 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? (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 |
|---|---|---|---|
| * | K072857 | Total Hip Prosthesis System Quadra S + Cocrmo Femoral Ball Head + ApricotSummary page 1…s 11 Device Product Code: LZO, JDI Predicate Devices: Medata Total Hip Prosthesis - Quadra S femoral stems, K072857, cleared on Feb. 4, 2008 Sulzer Orthopedics MS-30 Femoral Stem, K993043, cleared… | 2008 |
| * | K993043 | MS-30 Femoral StemSummary page 1…is - Quadra S femoral stems, K072857, cleared on Feb. 4, 2008 Sulzer Orthopedics MS-30 Femoral Stem, K993043, cleared on Dec. 2, 1999 Sulzer Orthopedics MS-30 Lateral Femoral Stems, K020713,… | 1999 |
| * | K020713 | MS-30 Lateral Femoral StemSummary page 1…MS-30 Femoral Stem, K993043, cleared on Dec. 2, 1999 Sulzer Orthopedics MS-30 Lateral Femoral Stems, K020713, cleared on May 14, 2002 Product Description: The Medacta Total Hip Prosthesis System - Quadra C femoral stem is… | 2002 |
What descends from it? (9)
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 |
|---|---|---|---|---|
| Dec 17, 2012 | Class II | Z-0791-2013 | Device Design | The tip of the Quadra Trial Broach size 0, broke during a surgery. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 15 years and passes through 3 companies; a new generation was cleared every 5.7 years on median.
- 2 of the 8 ancestors have a recall of any class.
- Of its descendants, K192827 (Medacta International S.A., 2020) has gone furthest, with 6 descendants of its own.
- 5 other devices also cite its predicate K072857.
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. 2009, 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 Medacta Total Hip Prosthesis System - Quadra C Femoral Stems are intended for cemented use in total or partial hip arthroplasty and in primary or revision surgery. Hip replacement is indicated in the following cases: Severely painful and/or disabled joint as a result of arthritis, traumatic arthritis, rheumatoid polyarthritis, or congenital hip dysplasia Avascular necrosis of the femoral head Acute traumatic fracture of the femoral head or neck…
Read the full statement (104 words)
The Medacta Total Hip Prosthesis System - Quadra C Femoral Stems are intended for cemented use in total or partial hip arthroplasty and in primary or revision surgery.
Hip replacement is indicated in the following cases:
Severely painful and/or disabled joint as a result of arthritis, traumatic arthritis, rheumatoid polyarthritis, or congenital hip dysplasia
Avascular necrosis of the femoral head
Acute traumatic fracture of the femoral head or neck
Failure of previous hip surgery, joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
Size 0 implants should not be implanted in patients with a mass of 65 kg or greater.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083558 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083558: Medacta Total Hip Prosthesis System - Quadra C.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083558
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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