510(k) · Cleared
ClearedSystem 12 X3 Acetabular Inserts; Series II X3 Acetabular Inserts
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Howmedica Osteonics Corp. · JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Cleared on Dec 2, 2005 after a 63-day review. The FDA summary names its predicate without a number. 1 later device descends from it.
- Decided
- Dec 2, 2005
- Review
- 63 days
- Class
- Class II
- Product code
- JDI
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK052748 System 12 X3 Acetabular Inserts; Series II X3 Acetabular InsertsHowmedica Osteonics Corp. · 2005
- Descendant · cites it directly · 0 of its ownK103124 Series II X3 Large Diameter Accetabular InsertsStryker Corporation · 2010
Most influential descendants
Showing 1 of 1 · See all- K103124Series II X3 Large Diameter Accetabular InsertsStryker Corporation · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K052748 | System 12 X3 Acetabular Inserts; Series II X3 Acetabular Inserts | Howmedica Osteonics Corp. | 2005 | — |
| +1 | K103124 | Series II X3 Large Diameter Accetabular Inserts | Stryker Corporation | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 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 JDI? 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 JDI device
- #1 K253515 Zimmer Biomet OSS™ Orthopedic Salvage System…score 15.2 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | — | System 12 and Series II Hip System Acetabular Inserts Named without a submission number |
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 |
|---|---|---|---|
| K103124 | Series II X3 Large Diameter Accetabular Inserts | 2010 | 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?
- Of its descendants, K103124 (Stryker Corporation, 2010) has gone furthest, with 0 descendants of its own.
How does its category compare?
All JDI devicesJDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JDI
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JDI
59in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JDI
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JDI
1,644in 2025
MAUDE reports naming product code JDI, 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 | 3 | 81 | 26 | 696 |
| 2008 | 5 | 96 | 6 | 810 |
| 2009 | 3 | 65 | 3 | 964 |
| 2010 | 0 | — | 3 | 2,040 |
| 2011 | 2 | — | 5 | 3,160 |
| 2012 | 4 | 167 | 4 | 5,122 |
| 2013 | 3 | 176 | 11 | 5,206 |
| 2014 | 3 | 98 | 3 | 4,968 |
| 2015 | 3 | 190 | 1 | 4,906 |
| 2016 | 4 | 166 | 5 | 3,995 |
| 2017 | 1 | — | 5 | 6,135 |
| 2018 | 1 | — | 1 | 6,728 |
| 2019 | 2 | — | 1 | 7,407 |
| 2020 | 7 | 247 | 77 | 4,015 |
| 2021 | 3 | 162 | 0 | 3,170 |
| 2022 | 3 | 69 | 0 | 1,978 |
| 2023 | 2 | — | 0 | 1,635 |
| 2024 | 3 | 59 | 0 | 1,821 |
| 2025 | 1 | — | 1 | 1,644 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The System 12® X3M' Acetabular inserts are single use sterile components, intended for use in conjunction with associated acetabular shells, femoral bearings, and femoral hip stems as part of a cemented or cementless total hip replacement procedure. Indications for use are as follows: noninflammatory degenerative joint disease including osteoatrthritis and avascular necrosis, rheumatoid arthritis, correction of functional deformity, revision procedures…
Read the full statement (203 words)
The System 12® X3M' Acetabular inserts are single use sterile components, intended for use in conjunction with associated acetabular shells, femoral bearings, and femoral hip stems as part of a cemented or cementless total hip replacement procedure. Indications for use are as follows:
noninflammatory degenerative joint disease including osteoatrthritis and avascular necrosis,
rheumatoid arthritis,
correction of functional deformity,
revision procedures where other treatments or devices have failed, and
treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
The Series II X3 Acetabular Inserts are single use sterile components, intended for use in conjunction with an associated Howmedica Osteonics metal acetabular shell, femoral bearing, and femoral hip stem as part of a cemented or cementless total hip arthroplasty. Indications for use are as follows:
Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis, or late stage avascular necrosis.
Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
Where bone stock is of poor quality or inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052748 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052748: System 12 X3 Acetabular Inserts; Series II X3 Acetabular Inserts.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052748
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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