510(k) · Cleared
ClearedACS® LD FB Knee System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Implantcast GmbH · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Cleared on Sep 6, 2024 as substantially equivalent to K173884 (Corin U.S.A. Limited, 2018) and 6 other predicates after a 260-day review. Its family tree reaches back 10 generations to 1994. 1 later device descends from it.
- Decided
- Sep 6, 2024
- Review
- 260 days
- Class
- Class II
- Product code
- JWH
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 10 generations to K941847 (1994). 95 ancestors in all, the oldest K840643 (1984). 1 later device descends from it, 1 citing it directly.
- 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 backK090988 GMK Total Knee SystemMedacta International S.A. · 2009 · Recalled
- 1 generation backK102437 GMK Revision Knee SystemMedacta International S.A. · 2010
- This deviceK234044 ACS® LD FB Knee SystemImplantcast GmbH · 2024
- Descendant · cites it directly · 0 of its ownK260037 implantcast Packaging System UpdateImplantcast GmbH · 2026
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 backK090988 GMK Total Knee SystemMedacta International S.A. · 2009 · Recalled
- 1 generation backK102437 GMK Revision Knee SystemMedacta International S.A. · 2010
- This deviceK234044 ACS® LD FB Knee SystemImplantcast GmbH · 2024
Most influential descendants
Showing 1 of 1 · See all- K260037implantcast Packaging System UpdateImplantcast GmbH · 2026 · cites it directly0descendants
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 | K090988 | GMK Total Knee System | Medacta International S.A. | 2009 | 1 |
| −1 | K102437 | GMK Revision Knee System | Medacta International S.A. | 2010 | — |
| 0 (this device) | K234044 | ACS® LD FB Knee System | Implantcast GmbH | 2024 | — |
| +1 | K260037 | implantcast Packaging System Update | Implantcast GmbH | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1987 | 2 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 3 | 0 |
| 1994 | 5 | 0 |
| 1995 | 5 | 0 |
| 1996 | 8 | 0 |
| 1997 | 4 | 0 |
| 1998 | 5 | 0 |
| 1999 | 3 | 0 |
| 2000 | 6 | 0 |
| 2001 | 8 | 0 |
| 2002 | 8 | 0 |
| 2003 | 5 | 0 |
| 2004 | 6 | 0 |
| 2005 | 3 | 0 |
| 2006 | 2 | 0 |
| 2007 | 3 | 0 |
| 2012 | 1 | 0 |
| 2018 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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 JWH? 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 JWH device
- #1 K221479 Persona Personalized Knee Systemscore 22.4 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (7)
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 |
|---|---|---|---|
| * | K173884 | Unity Total Knee SystemSummary page 5…ained cemented prosthesis Class: II Product Code: JWH Primary Predicate Corin USA Limited Unity™ Total Knee System (K173884) Device: Additional Predicate Stryker Corporation Scorpio® NRG and Scorpio® TS Knee Systems Devices:… | 2018 |
| * | K994128 | Scorpio Total Stablizer (TS) Total Knee SystemSummary page 5…ed Unity™ Total Knee System (K173884) Device: Additional Predicate Stryker Corporation Scorpio® NRG and Scorpio® TS Knee Systems Devices: (K994128, K011643, K041591, K042343) Medacta International, SA GMK® Primary and GMK® Revision… | 2000 |
| * | K011643 | Scorpio CR Superflex Tibial InsertSummary page 5…Total Knee System (K173884) Device: Additional Predicate Stryker Corporation Scorpio® NRG and Scorpio® TS Knee Systems Devices: (K994128, K011643, K041591, K042343) Medacta International, SA GMK® Primary and GMK® Revision… | 2001 |
| * | K041591 | Scorpio-Flex Posterior Stabilized Tibial Insert ComponentsSummary page 5…ee System (K173884) Device: Additional Predicate Stryker Corporation Scorpio® NRG and Scorpio® TS Knee Systems Devices: (K994128, K011643, K041591, K042343) Medacta International, SA GMK® Primary and GMK® Revision Kn… | 2004 |
| * | K042343 | Scorpio NRG Knee SystemSummary page 5…(K173884) Device: Additional Predicate Stryker Corporation Scorpio® NRG and Scorpio® TS Knee Systems Devices: (K994128, K011643, K041591, K042343) Medacta International, SA GMK® Primary and GMK® Revision Knee System… | 2005 |
| * | K090988 | GMK Total Knee SystemSummary page 5…(K994128, K011643, K041591, K042343) Medacta International, SA GMK® Primary and GMK® Revision Knee Systems (K090988, K102437) Indications for Use: General total knee arthroplasty indications include: • Painful, disabling joint disease o… | 2009 |
| * | K102437 | GMK Revision Knee SystemSummary page 5…8, K011643, K041591, K042343) Medacta International, SA GMK® Primary and GMK® Revision Knee Systems (K090988, K102437) Indications for Use: General total knee arthroplasty indications include: • Painful, disabling joint disease of the kne… | 2010 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K260037 | implantcast Packaging System Update | 2026 | 0 |
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 30 years and passes through 7 companies; a new generation was cleared every 1.8 years on median.
- 43 of the 94 ancestors have a recall of any class.
- Of its descendants, K260037 (Implantcast GmbH, 2026) has gone furthest, with 0 descendants of its own.
How does its category compare?
All JWH devicesJWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · JWH
20in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JWH
55in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JWH
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JWH
9,306in 2025
MAUDE reports naming product code JWH, 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 | 18 | 74 | 14 | 1,305 |
| 2008 | 17 | 81 | 10 | 1,483 |
| 2009 | 11 | 168 | 109 | 1,870 |
| 2010 | 19 | 85 | 32 | 3,286 |
| 2011 | 25 | 87 | 27 | 5,133 |
| 2012 | 33 | 85 | 85 | 5,203 |
| 2013 | 31 | 128 | 31 | 6,135 |
| 2014 | 33 | 98 | 13 | 6,722 |
| 2015 | 27 | 87 | 11 | 6,881 |
| 2016 | 18 | 88 | 17 | 7,586 |
| 2017 | 25 | 118 | 61 | 12,263 |
| 2018 | 25 | 90 | 14 | 14,071 |
| 2019 | 28 | 133 | 5 | 14,987 |
| 2020 | 22 | 59 | 2 | 12,592 |
| 2021 | 24 | 61 | 8 | 9,408 |
| 2022 | 17 | 56 | 12 | 8,364 |
| 2023 | 20 | 57 | 67 | 8,947 |
| 2024 | 19 | 89 | 7 | 10,828 |
| 2025 | 20 | 55 | 2 | 9,306 |
| 2026 | 12 | 63 | 4 | — |
What is it indicated for?
General total knee arthroplasty indications include: Painful, disabling joint disease of the knee resulting from: degenerative arthritis, rheumatoid arthritis or post-traumatic arthritis Post-traumatic loss of knee joint configuration and function Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function Revision of previous unsuccessful knee replacement or other procedure, where soft tissue…
Read the full statement (165 words)
General total knee arthroplasty indications include:
Painful, disabling joint disease of the knee resulting from: degenerative arthritis, rheumatoid arthritis or post-traumatic arthritis
Post-traumatic loss of knee joint configuration and function
Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function
Revision of previous unsuccessful knee replacement or other procedure, where soft tissue stability is adequate
Fracture of the distal femur and/or proximal tibia that cannot be stabilized by standard fracture management techniques
The posterior stabilized variant is also indicated for PCL instability requiring implant bearing surface geometries with increased anterior-posterior constraint and absent or non-functioning posterior cruciate ligament.
The ACS® LD FB Knee System is intended for cemented use, single use only.
The ACS® LD FB Knee System is intended for use in total knee arthroplasty in skeletally mature patients, to provide increased mobility and reduce pain by replacing the damaged knee joint articulation where there is evidence of sufficient sound bone to seat and support the components.
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/K234044 · printed Nov 4, 2026
Cite this page
510(k) Report. “K234044: ACS® LD FB Knee System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K234044
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