510(k) · Cleared
Recalled · Class II · 2024Ringloc BI-Polar Acetabular Component
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet, Inc. · JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Cleared on Sep 29, 2005 as substantially equivalent to K833175 (Biomet, Inc., 1983) and 1 other predicate after a 107-day review. Its family tree reaches back 1 generation to 1983. 25 later devices descend from it. It has been recalled 4 times.
- Decided
- Sep 29, 2005
- Review
- 107 days
- Class
- Class II
- Product code
- JDI
- Recalls
- 4
- Predicates
- 2
Its longest line of descent runs back 1 generation to K833175 (1983). 2 ancestors in all. 25 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK833175 Biomet Bipolar ProsthesisBiomet, Inc. · 1983
- This deviceK051569 Ringloc BI-Polar Acetabular ComponentBiomet, Inc. · 2005
- Descendant · cites it directly · 11 of its ownK060707 Aesculap Bipolar Acetabular CupAesculap, Inc. · 2006
- Descendant · cites it directly · 10 of its ownK112019 Bencox ID Stem, Bencox Metal Head, Bencox Bipolar CupCorentec Co., Ltd. · 2011
- Descendant · 2 generations on · 8 of its ownK121665 Bencox Foret & Bencox DeltaCorentec Co., Ltd. · 2012
- Descendant · 2 generations on · 7 of its ownK150007 Modified Bencox Hip SystemCorentec Co., Ltd. · 2015
- Descendant · 3 generations on · 6 of its ownK162127 Bencox M Stem Lateralized & Bencox Mirabo Cup SystemCorentec Co., Ltd. · 2016 · Recalled
Showing 5 of 25 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 25 · See all- K060707Aesculap Bipolar Acetabular CupAesculap, Inc. · 2006 · cites it directly11descendants
- K112019Bencox ID Stem, Bencox Metal Head, Bencox Bipolar CupCorentec Co., Ltd. · 2011 · cites it directly10descendants
- K121665Bencox Foret & Bencox DeltaCorentec Co., Ltd. · 2012 · 2 generations on8descendants
- K150007Modified Bencox Hip SystemCorentec Co., Ltd. · 2015 · 2 generations on7descendants
- K162127Bencox M Stem Lateralized & Bencox Mirabo Cup SystemCorentec Co., Ltd. · 2016 · 3 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K833175 | Biomet Bipolar Prosthesis | Biomet, Inc. | 1983 | — |
| 0 (this device) | K051569 | Ringloc BI-Polar Acetabular Component | Biomet, Inc. | 2005 | — |
| +1 | K060707 | Aesculap Bipolar Acetabular Cup | Aesculap, Inc. | 2006 | — |
| +1 | K112019 | Bencox ID Stem, Bencox Metal Head, Bencox Bipolar Cup | Corentec Co., Ltd. | 2011 | — |
| +2 | K121665 | Bencox Foret & Bencox Delta | Corentec Co., Ltd. | 2012 | — |
| +2 | K150007 | Modified Bencox Hip System | Corentec Co., Ltd. | 2015 | — |
| +3 | K162127 | Bencox M Stem Lateralized & Bencox Mirabo Cup System | Corentec Co., Ltd. | 2016 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 4 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 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 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? (2)
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 |
|---|---|---|---|
| * | K833175 | Biomet Bipolar ProsthesisSummary page 1…-hip) metal/polymer cemented or uncemented prosthesis (21 CFR 888.3390) Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Biomet Bipolar Prosthesis (K833175), and Biomet TriPolar System (K991990) Device Description: The Bi-Polar device consists of a large outer shell with a polyethyle… | 1983 |
| * | K991990 | Tri-Polar SystemSummary page 1…nted prosthesis (21 CFR 888.3390) Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Biomet Bipolar Prosthesis (K833175), and Biomet TriPolar System (K991990) Device Description: The Bi-Polar device consists of a large outer shell with a polyethylene insert that captures a modular head… | 1999 |
What descends from it? (25)
See all 254 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 17, 2024 | Class II | Z-2179-2024 | Labeling mix-ups | 41 mm acetabular outer heads were potentially assembled with a 42 mm locking ring, may lead to joint instability leading requiring surgical intervention |
| Nov 25, 2020 | Class II | Z-0628-2021 | Process control | Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device. |
| Sep 3, 2020 | Class II | Z-0097-2021 | Process control | Zimmer Biomet is conducting a medical device recall for three lots of the RingLoc Bi-Polar Hip system Acetabular Cup. The affected lots were gamma sterilized twice. Sufficient data does not exist to support the functionality, shelf life… |
| Feb 17, 2017 | Class II | Z-1860-2017 | Process design | Endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 2 ancestors has a recall.
- Of its descendants, K060707 (Aesculap, Inc., 2006) has gone furthest, with 11 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?
1. Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis
2. Rheumatoid arthritis
3. Correction of functional deformity
4. Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051569 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051569: Ringloc BI-Polar Acetabular Component.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051569
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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