510(k) · Cleared
ClearedPrevision Hip System with Recon Ring
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aesculap Implant Systems, LLC · MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Cleared on Dec 9, 2010 as substantially equivalent to K992667 (Zimmer, Inc., 1999) and 4 other predicates after a 106-day review. Its family tree reaches back 8 generations to 1996.
- Decided
- Dec 9, 2010
- Review
- 106 days
- Class
- Class II
- Product code
- MEH
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 8 generations to K955033 (1996). 86 ancestors in all, the oldest K840643 (1984). No later device cites it as a predicate yet.
- Root · 8 generations backK955033 Rim Flare Acetabular ComponentIntermedics Orthopedics · 1996
- 7 generations backK983509 Inter-OP Acetabular System - Durasul Acetabular InsertSulzer Orthopedics, Inc. · 1999
- 6 generations backK993259 Inter-OP Durasul Acetabular Inserts/Cocr Femoral HeadsSulzer Orthopedics, Inc. · 2000 · Recalled
- 5 generations backK022902 Smith & Nephew Hip SystemSmith & Nephew, Inc. · 2002
- 4 generations backK040191 Bicontact Hip Stem and Femoral HeadAesculap · 2004
- 3 generations backK043079 Bicontact Hip System with U-CapAesculap · 2004
- 2 generations backK060437 Excia Total Hip System with U-CapAesculap, Inc. · 2006
- 1 generation backK071916 Metha Hip SystemAesculap Implant Systems, Inc. · 2008 · Recalled
- This deviceK102424 Prevision Hip System with Recon RingAesculap Implant Systems, LLC · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K955033 | Rim Flare Acetabular Component | Intermedics Orthopedics | 1996 | — |
| −7 | K983509 | Inter-OP Acetabular System - Durasul Acetabular Insert | Sulzer Orthopedics, Inc. | 1999 | — |
| −6 | K993259 | Inter-OP Durasul Acetabular Inserts/Cocr Femoral Heads | Sulzer Orthopedics, Inc. | 2000 | 3 |
| −5 | K022902 | Smith & Nephew Hip System | Smith & Nephew, Inc. | 2002 | — |
| −4 | K040191 | Bicontact Hip Stem and Femoral Head | Aesculap | 2004 | — |
| −3 | K043079 | Bicontact Hip System with U-Cap | Aesculap | 2004 | — |
| −2 | K060437 | Excia Total Hip System with U-Cap | Aesculap, Inc. | 2006 | — |
| −1 | K071916 | Metha Hip System | Aesculap Implant Systems, Inc. | 2008 | 1 |
| 0 (this device) | K102424 | Prevision Hip System with Recon Ring | Aesculap Implant Systems, LLC | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1987 | 2 | 0 |
| 1990 | 2 | 0 |
| 1991 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 12 | 0 |
| 1995 | 10 | 0 |
| 1996 | 9 | 0 |
| 1997 | 6 | 0 |
| 1998 | 5 | 0 |
| 1999 | 2 | 0 |
| 2000 | 9 | 0 |
| 2001 | 4 | 0 |
| 2002 | 4 | 0 |
| 2003 | 4 | 0 |
| 2004 | 1 | 0 |
| 2005 | 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 MEH? 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 MEH device
- #1 K210581 Actis DuoFix Hip Prosthesis- Collarlessscore 23.9 · 16 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
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 |
|---|---|---|---|
| * | K992667 | ZMR Hip System-Revision TaperSummary page 1…AL EQUIVALENCE Aesculap Implant Systems, LLC believes that the Prevision Hip System with Recon Ring is substantially equivalent to: * Zimmer, Inc. ZMR Hip System (K992667 & K994286) * Intermedics Orthopedics Inc., Burch/Schneider Reinforcement Cage (K960678) * Aesculap Implant Systems… | 1999 |
| * | K994286 | ZMR Hip System-Porous RevisionSummary page 1…ENCE Aesculap Implant Systems, LLC believes that the Prevision Hip System with Recon Ring is substantially equivalent to: * Zimmer, Inc. ZMR Hip System (K992667 & K994286) * Intermedics Orthopedics Inc., Burch/Schneider Reinforcement Cage (K960678) * Aesculap Implant Systems Metha Hip… | 2000 |
| * | K960678 | Burch/Schneider Reinforcement CageSummary page 1…Ring is substantially equivalent to: * Zimmer, Inc. ZMR Hip System (K992667 & K994286) * Intermedics Orthopedics Inc., Burch/Schneider Reinforcement Cage (K960678) * Aesculap Implant Systems Metha Hip System (K071916) * Aesculap Implant Systems Bicontact (K040191) DEVICE DESCR… | 1996 |
| * | K071916 | Metha Hip SystemSummary page 1…MR Hip System (K992667 & K994286) * Intermedics Orthopedics Inc., Burch/Schneider Reinforcement Cage (K960678) * Aesculap Implant Systems Metha Hip System (K071916) * Aesculap Implant Systems Bicontact (K040191) DEVICE DESCRIPTION The Prevision Hip System is a modular system which con… | 2008 |
| * | K040191 | Bicontact Hip Stem and Femoral HeadSummary page 1…Orthopedics Inc., Burch/Schneider Reinforcement Cage (K960678) * Aesculap Implant Systems Metha Hip System (K071916) * Aesculap Implant Systems Bicontact (K040191) DEVICE DESCRIPTION The Prevision Hip System is a modular system which consists of a proximal body, distal stem and a tension nu… | 2004 |
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 14 years and passes through 7 companies; a new generation was cleared every 2.2 years on median.
- 26 of the 85 ancestors have a recall of any class.
- 6 other devices also cite its predicate K992667.
How does its category compare?
All MEH devicesMEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · MEH
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MEH
87in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MEH
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MEH
470in 2025
MAUDE reports naming product code MEH, 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 | 2 | — | 3 | 25 |
| 2008 | 6 | 79 | 80 | 261 |
| 2009 | 6 | 65 | 51 | 539 |
| 2010 | 5 | 226 | 16 | 462 |
| 2011 | 5 | 95 | 4 | 419 |
| 2012 | 6 | 131 | 3 | 1,606 |
| 2013 | 1 | — | 0 | 1,295 |
| 2014 | 0 | — | 1 | 1,196 |
| 2015 | 2 | — | 1 | 490 |
| 2016 | 6 | 163 | 4 | 347 |
| 2017 | 3 | 209 | 1 | 383 |
| 2018 | 2 | — | 3 | 337 |
| 2019 | 1 | — | 0 | 335 |
| 2020 | 3 | 131 | 1 | 338 |
| 2021 | 3 | 83 | 0 | 372 |
| 2022 | 3 | 150 | 0 | 316 |
| 2023 | 2 | — | 0 | 334 |
| 2024 | 6 | 91 | 0 | 354 |
| 2025 | 5 | 87 | 1 | 470 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
The Prevision Hip System is intended for cementless 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 Prevision Hip System is intended for revision only. The Recon Ring is intended to bridge the areas of acetabular bone loss in patients with acetabular bone deficiency. Inaddition, the…
Read the full statement (167 words)
The Prevision Hip System is intended for cementless 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 Prevision Hip System is intended for revision only.
The Recon Ring is intended to bridge the areas of acetabular bone loss in patients with acetabular bone deficiency. Inaddition, the Recon Ring is intended to provide support for an all polyethylene acetabular implant in a cemented application.
Diagnostic indications for use of this device include acetabular dlysplasia, osteoporosis, protrusion acetabuli, cystic acetabular roof, reconstruction in cases of defects after fracture, acetabular loosening, tumors or revision surgery.
The general indications associated with the use of the Recon Ring in total hip arthroplasty include:
* Advanced joint destruction resulting from degenerative, posttraumatic or rheumatoid arthritis,
* Fracture or avascular necrosis of the femoral head,
* Failed previous surgery, e.g. osteosynthesis, joint reconstruction, arthrodesis, hemi-arthroplasty and total hip replacement.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102424 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102424: Prevision Hip System with Recon Ring.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102424
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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