510(k) · Cleared
ClearedPlasmafit Acetabular Cup and Vitelene Insert
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aesculap Implant System, Inc. · OQG Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented
Cleared on Oct 30, 2013 as substantially equivalent to K042344 (Aesculap, Inc., 2005) and 4 other predicates after a 414-day review. Its family tree reaches back 10 generations to 1994.
- Decided
- Oct 30, 2013
- Review
- 414 days
- Class
- Class II
- Product code
- OQG
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 10 generations to K941847 (1994). 187 ancestors in all, the oldest K810258 (1981). No later device cites it as a predicate yet.
- Root · 10 generations backK941847 5/8 Porocoat Aml Hip Porocoat Porous CoatingDepuy, Inc. · 1994
- 6 generations between
- 3 generations backK081023 Evolis Total Knee SystemMedacta International S.A. · 2008 · Recalled
- 2 generations backK091069 Medacta Bone Screws - Evolis and VersafitMedacta International S.A. · 2009
- 1 generation backK103721 Mpact Acetabular SystemMedacta International · 2011
- This deviceK122783 Plasmafit Acetabular Cup and Vitelene InsertAesculap Implant System, Inc. · 2013
Show all 10 generations
- Root · 10 generations backK941847 5/8 Porocoat Aml Hip Porocoat Porous CoatingDepuy, Inc. · 1994
- 9 generations backK964650 TCP-Coated Porocoat Aml Femoral Hip ProsthesisDepuy, Inc. · 1997
- 8 generations backK980711 Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic…Zimmer, Inc. · 1998 · Recalled
- 7 generations backK001277 Triflange Acetabular Cup SystemDePuy Orthopaedics, Inc. · 2000
- 6 generations backK031495 Pinnacle Duofix HA Acetabular Cup ProsthesisDePuy Orthopaedics, Inc. · 2003
- 5 generations backK042344 Excia Total Hip SystemAesculap, Inc. · 2005 · Recalled
- 4 generations backK070981 Search Evolution (LC) Total Knee System (Plasmapore)Aesculap Implant Systems, Inc. · 2007
- 3 generations backK081023 Evolis Total Knee SystemMedacta International S.A. · 2008 · Recalled
- 2 generations backK091069 Medacta Bone Screws - Evolis and VersafitMedacta International S.A. · 2009
- 1 generation backK103721 Mpact Acetabular SystemMedacta International · 2011
- This deviceK122783 Plasmafit Acetabular Cup and Vitelene InsertAesculap Implant System, Inc. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K941847 | 5/8 Porocoat Aml Hip Porocoat Porous Coating | Depuy, Inc. | 1994 | — |
| −9 | K964650 | TCP-Coated Porocoat Aml Femoral Hip Prosthesis | Depuy, Inc. | 1997 | — |
| −8 | K980711 | Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic Coating | Zimmer, Inc. | 1998 | 1 |
| −7 | K001277 | Triflange Acetabular Cup System | DePuy Orthopaedics, Inc. | 2000 | — |
| −6 | K031495 | Pinnacle Duofix HA Acetabular Cup Prosthesis | DePuy Orthopaedics, Inc. | 2003 | — |
| −5 | K042344 | Excia Total Hip System | Aesculap, Inc. | 2005 | 10 |
| −4 | K070981 | Search Evolution (LC) Total Knee System (Plasmapore) | Aesculap Implant Systems, Inc. | 2007 | — |
| −3 | K081023 | Evolis Total Knee System | Medacta International S.A. | 2008 | 1 |
| −2 | K091069 | Medacta Bone Screws - Evolis and Versafit | Medacta International S.A. | 2009 | — |
| −1 | K103721 | Mpact Acetabular System | Medacta International | 2011 | — |
| 0 (this device) | K122783 | Plasmafit Acetabular Cup and Vitelene Insert | Aesculap Implant System, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1987 | 2 | 0 |
| 1988 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 3 | 0 |
| 1992 | 6 | 0 |
| 1993 | 3 | 0 |
| 1994 | 15 | 0 |
| 1995 | 13 | 0 |
| 1996 | 12 | 0 |
| 1997 | 10 | 0 |
| 1998 | 8 | 0 |
| 1999 | 6 | 0 |
| 2000 | 17 | 0 |
| 2001 | 9 | 0 |
| 2002 | 12 | 0 |
| 2003 | 9 | 0 |
| 2004 | 6 | 0 |
| 2005 | 6 | 0 |
| 2006 | 8 | 0 |
| 2007 | 11 | 0 |
| 2008 | 5 | 0 |
| 2009 | 2 | 0 |
| 2010 | 4 | 0 |
| 2011 | 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 OQG? 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 OQG device
- #1 K200328 Tesera Trabecular Technologies (T3) Acetabular…score 4.7 · 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? (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 |
|---|---|---|---|
| * | K042344 | Excia Total Hip SystemSummary page 3…ant Systems, LLC believes that the Plasmafit Pro Acetabular Cup System and Vitelene insert is substantially equivalent to: * Excia Total Hip System (Aesculap - K<042344) * Excia Total Hip System (Aesculap - K<061699) * EXp Acetabular Shell Insert (StelKast, Inc. - K<094035) *… | 2005 |
| * | K061699 | EXCIASummary page 3…ular Cup System and Vitelene insert is substantially equivalent to: * Excia Total Hip System (Aesculap - K<042344) * Excia Total Hip System (Aesculap - K<061699) * EXp Acetabular Shell Insert (StelKast, Inc. - K<094035) * Mectacer 4omm Biolox Delta Heads (111215) *… | 2006 |
| * | K094035 | Exp Acetabular Liner, Models SC3342 Non-Hooded 28MM, SC3343 Hooded 28MMSummary page 3…: * Excia Total Hip System (Aesculap - K<042344) * Excia Total Hip System (Aesculap - K<061699) * EXp Acetabular Shell Insert (StelKast, Inc. - K<094035) * Mectacer 4omm Biolox Delta Heads (111215) * Mpact 40mm Ball Heads (1103721) TECHNOLOGICAL CHARACTERISTICS (com… | 2011 |
| * | K112115 | Mectacer Biolox (R) Delta Femoral Heads Our reading of the summary gave K111215, FDA’s number for Ascom Mobile Monitoring Gateway (MMG) (Ascom (Sweden) AB). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “Mectacer 40mm Biolox Delta Heads”. | 2011 |
| * | K103721 | Mpact Acetabular SystemSummary page 3…culap - K<061699) * EXp Acetabular Shell Insert (StelKast, Inc. - K<094035) * Mectacer 4omm Biolox Delta Heads (111215) * Mpact 40mm Ball Heads (1103721) TECHNOLOGICAL CHARACTERISTICS (compared to Predicate(s)) Aesculap Implant Systems Plasmafit Pro Acetabular Cup and Vitelene Inse… | 2011 |
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 19 years and passes through 8 companies; a new generation was cleared every 1.8 years on median.
- 53 of the 186 ancestors have a recall of any class.
- 16 other devices also cite its predicate K042344.
How does its category compare?
All OQG devicesOQG Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · OQG
2in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · OQG
99in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OQG
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OQG
16in 2025
MAUDE reports naming product code OQG, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 5 | 144 | 0 | 0 |
| 2013 | 3 | 280 | 1 | 5 |
| 2014 | 3 | 99 | 0 | 31 |
| 2015 | 1 | — | 0 | 52 |
| 2016 | 0 | — | 0 | 45 |
| 2017 | 3 | 99 | 0 | 27 |
| 2018 | 0 | — | 0 | 43 |
| 2019 | 0 | — | 0 | 104 |
| 2020 | 2 | — | 0 | 178 |
| 2021 | 2 | — | 0 | 88 |
| 2022 | 0 | — | 0 | 32 |
| 2023 | 0 | — | 0 | 18 |
| 2024 | 0 | — | 0 | 20 |
| 2025 | 0 | — | 0 | 16 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Plasmafit Pro Acetabular Cup System and Vitelene Insert are intended for use with existing Aesculap femoral heads and femoral stems to replace the hip joint. The devices are intended for: * Patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head and nonunion of previous fractures of the femur * Patients with…
Read the full statement (106 words)
The Plasmafit Pro Acetabular Cup System and Vitelene Insert are intended for use with existing Aesculap femoral heads and femoral stems to replace the hip joint.
The devices are intended for:
* Patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head and nonunion of previous fractures of the femur
* Patients with congenital hip dlysplasia, protrusion acetabuli, or slipped capital femoral ephiphysis
* Patients suffering from disability due to previous fusion
* Patients with acute femoral neck fractures
Plasmafit Pro Acetabular Cup System and Vitelene Insert are intended for cementless applications.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122783 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122783: Plasmafit Acetabular Cup and Vitelene Insert.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122783
Report an extraction error
Are you the manufacturer?
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