510(k) · Cleared
ClearedAugment and Screw, Psa Type
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
United Orthopedic Corp. · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Cleared on Feb 5, 2013 as substantially equivalent to K082424 (United Orthopedic Corp., 2008) and 2 other predicates after a 197-day review. Its family tree reaches back 4 generations to 1992. 10 later devices descend from it.
- Decided
- Feb 5, 2013
- Review
- 197 days
- Class
- Class II
- Product code
- JWH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K915132 (1992). 10 ancestors in all. 10 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK915132 MCK Maximum Congruent Knee) Knee SystemBiomet, Inc. · 1992 · Recalled
- 3 generations backK023546 Maxim Accel Knee SystemBiomet, Inc. · 2003 · Recalled
- 2 generations backK042757 Vanguard SSK Knee SystemBiomet, Inc. · 2005 · Recalled
- 1 generation backK093293 Vanguard 360 Revision Knee SystemBiomet, Inc. · 2010 · Recalled
- This deviceK122183 Augment and Screw, Psa TypeUnited Orthopedic Corp. · 2013
- Descendant · cites it directly · 5 of its ownK131864 U2 Tibial Baseplate- Cma Type, Tibial Insert and AugmentUnited Orthopedic Corporation · 2014
- Descendant · 2 generations on · 3 of its ownK150829 U2 Total Knee System- Additional SizesUnited Orthopedic Corporation · 2015
- Descendant · cites it directly · 2 of its ownK190100 USTAR II SystemUnited Orthopedic Corporation · 2019 · Recalled
- Descendant · 2 generations on · 1 of its ownK161705 U2 Total Knee System E-XPE productsUnited Orthopedic Corporation · 2017
- Descendant · 2 generations on · 0 of its ownK252303 Stem Extension Line (USTAR II System)United Orthopedic Corporation · 2025
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K131864U2 Tibial Baseplate- Cma Type, Tibial Insert and AugmentUnited Orthopedic Corporation · 2014 · cites it directly5descendants
- K150829U2 Total Knee System- Additional SizesUnited Orthopedic Corporation · 2015 · 2 generations on3descendants
- K190100USTAR II SystemUnited Orthopedic Corporation · 2019 · cites it directly2descendants
- K161705U2 Total Knee System E-XPE productsUnited Orthopedic Corporation · 2017 · 2 generations on1descendant
- K252303Stem Extension Line (USTAR II System)United Orthopedic Corporation · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K915132 | MCK Maximum Congruent Knee) Knee System | Biomet, Inc. | 1992 | 6 |
| −3 | K023546 | Maxim Accel Knee System | Biomet, Inc. | 2003 | 13 |
| −2 | K042757 | Vanguard SSK Knee System | Biomet, Inc. | 2005 | 1 |
| −1 | K093293 | Vanguard 360 Revision Knee System | Biomet, Inc. | 2010 | 5 |
| 0 (this device) | K122183 | Augment and Screw, Psa Type | United Orthopedic Corp. | 2013 | — |
| +1 | K131864 | U2 Tibial Baseplate- Cma Type, Tibial Insert and Augment | United Orthopedic Corporation | 2014 | — |
| +2 | K150829 | U2 Total Knee System- Additional Sizes | United Orthopedic Corporation | 2015 | — |
| +1 | K190100 | USTAR II System | United Orthopedic Corporation | 2019 | 5 |
| +2 | K161705 | U2 Total Knee System E-XPE products | United Orthopedic Corporation | 2017 | — |
| +2 | K252303 | Stem Extension Line (USTAR II System) | United Orthopedic Corporation | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 2 | 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 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? (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 |
|---|---|---|---|
| * | K082424 | United U2 Total Knee SystemSummary page 1…Class 11 Panel Code Orthopaedics Oevice Device Product Code: JWH Predicate Device: 1. "UNITED" U2 Total Knee System - PSA Type (K082424) 2. "Zimmer" NexGen Complete Knee Solution Legacy CCK Type (K960279)… | 2008 |
| * | K960279 | Nexgen Compl. Knee Sol. Legacy Posterior Stabilized/Constrained Condylar Knee Femoral…Summary page 1…1. "UNITED" U2 Total Knee System - PSA Type (K082424) 2. "Zimmer" NexGen Complete Knee Solution Legacy CCK Type (K960279) 3. "BIOMET" Vanguard 360 Revision Knee System (K093293) Device Descrip… | 1996 |
| * | K093293 | Vanguard 360 Revision Knee SystemSummary page 1…e Solution Legacy CCK Type (K960279) 3. "BIOMET" Vanguard 360 Revision Knee System (K093293) Device Description: "UNITED" Augment and Screw - PSA Type, including femoral augments - distal only and tibial augment… | 2010 |
What descends from it? (10)
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)
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 21 years and passes through 2 companies; a new generation was cleared every 5.7 years on median.
- 8 of the 10 ancestors have a recall of any class.
- Of its descendants, K131864 (United Orthopedic Corporation, 2014) has gone furthest, with 5 descendants of its own.
- 8 other devices also cite its predicate K082424.
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. 2013, 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?
This device is indicated in knee arthroplasty in skeletally mature patients with severe knee pain and disability due to rheumatoid arthritis, osteoarthritis, primary and secondary traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral condyle or pseudogout, posttraumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy, moderate valgus, varus, or flexion…
Read the full statement (120 words)
This device is indicated in knee arthroplasty in skeletally mature patients with severe knee pain and disability due to rheumatoid arthritis, osteoarthritis, primary and secondary traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral condyle or pseudogout, posttraumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy, moderate valgus, varus, or flexion contraction. This device is intended for use in patients who require augmentation and/or stem extensions due to inadequate bone stock and/or require increased stabilization for tibiofemoral joint due to soft tissue imbalance. The femoral and tibial augments are to be attached to their respective components with a fixation screw or screws.
Note: In the US, this device is for cemented use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122183 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122183: Augment and Screw, Psa Type.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122183
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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