510(k) · Cleared
Recalled · Class II · 2018Ringloc 36MM Line and Modular Femoral Heads
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 Aug 21, 2003 as substantially equivalent to K970501 (Biomet, Inc., 1997) and 1 other predicate after a 17-day review. Its family tree reaches back 2 generations to 1981. 505 later devices descend from it. It has been recalled 3 times.
- Decided
- Aug 21, 2003
- Review
- 17 days
- Class
- Class II
- Product code
- JDI
- Recalls
- 3
- Predicates
- 2
Its longest line of descent runs back 2 generations to K810258 (1981). 5 ancestors in all. 505 later devices descend from it, 10 citing it directly.
- Root · 2 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 1 generation backK974558 Salvage/Onocology Hip and Total Femur SystemBiomet, Inc. · 1998
- This deviceK032396 Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc. · 2003
- Descendant · cites it directly · 355 of its ownK042051 Arcomxl Polyethylene LinersBiomet, Inc. · 2005 · Recalled
- Descendant · 2 generations on · 344 of its ownK051411 Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc. · 2005 · Recalled
- Descendant · 3 generations on · 343 of its ownK061312 36MM Biolox Delta Ceramic HeadsBiomet, Inc. · 2006
- Descendant · cites it directly · 289 of its ownK050327 E-Poly (Vitamin E) Acetabular LinersBiomet, Inc. · 2005
- Descendant · 2 generations on · 286 of its ownK070364 100KGY E-Poly Maxrom Acetabular LinersBiomet, Inc. · 2007
Showing 5 of 505 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 505 · See all- K042051Arcomxl Polyethylene LinersBiomet, Inc. · 2005 · cites it directly355descendants
- K051411Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc. · 2005 · 2 generations on344descendants
- K06131236MM Biolox Delta Ceramic HeadsBiomet, Inc. · 2006 · 3 generations on343descendants
- K050327E-Poly (Vitamin E) Acetabular LinersBiomet, Inc. · 2005 · cites it directly289descendants
- K070364100KGY E-Poly Maxrom Acetabular LinersBiomet, Inc. · 2007 · 2 generations on286descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K810258 | Proximal Fermoral Hip Replacement | Biomet, Inc. | 1981 | — |
| −1 | K974558 | Salvage/Onocology Hip and Total Femur System | Biomet, Inc. | 1998 | — |
| 0 (this device) | K032396 | Ringloc 36MM Line and Modular Femoral Heads | Biomet, Inc. | 2003 | — |
| +1 | K042051 | Arcomxl Polyethylene Liners | Biomet, Inc. | 2005 | 1 |
| +2 | K051411 | Arcomxl Polyethylene Liners and Biolox Delta Heads | Biomet, Inc. | 2005 | 1 |
| +3 | K061312 | 36MM Biolox Delta Ceramic Heads | Biomet, Inc. | 2006 | — |
| +1 | K050327 | E-Poly (Vitamin E) Acetabular Liners | Biomet, Inc. | 2005 | — |
| +2 | K070364 | 100KGY E-Poly Maxrom Acetabular Liners | Biomet, Inc. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 3 | 0 |
| 2006 | 2 | 0 |
| 2007 | 5 | 0 |
| 2008 | 4 | 0 |
| 2009 | 6 | 0 |
| 2010 | 8 | 0 |
| 2011 | 14 | 0 |
| 2012 | 26 | 0 |
| 2013 | 34 | 0 |
| 2014 | 29 | 0 |
| 2015 | 24 | 0 |
| 2016 | 26 | 0 |
| 2017 | 22 | 0 |
| 2018 | 26 | 0 |
| 2019 | 37 | 0 |
| 2020 | 34 | 0 |
| 2021 | 32 | 0 |
| 2022 | 34 | 0 |
| 2023 | 32 | 0 |
| 2024 | 34 | 0 |
| 2025 | 39 | 0 |
| 2026 | 34 | 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 |
|---|---|---|---|
| * | K970501 | Pegged Acetabular ComponentSummary page 1…onstrained cemented prosthesis (2 1 CFR 9888.3350). Legally Marketed Devices To Which Substantial Equivalence Is Claimed: RingLocB 32mm Liners cleared in 5 10(k) K970501, and 32mm Modular Femoral Heads cleared in 5 1O(k) K974558. Device Description: The RingLocO 36mm Liners are manufac… | 1997 |
| * | K974558 | Salvage/Onocology Hip and Total Femur SystemSummary page 1…ted Devices To Which Substantial Equivalence Is Claimed: RingLocB 32mm Liners cleared in 5 10(k) K970501, and 32mm Modular Femoral Heads cleared in 5 1O(k) K974558. Device Description: The RingLocO 36mm Liners are manufactured from ArConiB processed ultra-high molecular weight polye… | 1998 |
What descends from it? (505)
See all 50510 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K042051 | Arcomxl Polyethylene Liners | 2005 | 355 |
| K050327 | E-Poly (Vitamin E) Acetabular Liners | 2005 | 289 |
| K094035 | Exp Acetabular Liner, Models SC3342 Non-Hooded 28MM, SC3343 Hooded 28MM | 2011 | 79 |
| K070061 | 36MM Cocr Femoral Head and 36MM Acetabular Insert | 2007 | 38 |
| K101336 | E1 Avantage Head | 2011 | 24 |
| K110555 | Arcomxl Active Articulation | 2011 | 22 |
| K112897 | Renovis Surgical Hip Joint Replacement Prosthesis | 2012 | 8 |
| K121636 | Zenith, Femoral Stem Zenith, Distal Centralizer Fomoral Head Acetabular Insert | 2012 | 1 |
| K181491 | Delta Dual Mobility System | 2019 | 0 |
| K062997 | Arcomxl Polyethylene Liners and 38/40MM Femoral Heads | 2006 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 2, 2018 | Class II | Z-1538-2018 | Nonconforming Material/Component | Two lots of different sized modular heads potentially commingled. Risks include delay in surgery and dislocation due to use of an incorrect sized head. |
| Sep 15, 2017 | Class II | Z-1008-2018 | Error in labeling | One piece from a different lot mixed with lot 236840 and is incorrectly etched as -6MM offset instead of +3MM offset. As the incorrect etching and related size difference affects the functional use of this product, the affected lot is… |
| 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?
- The line of descent spans 22 years and passes through 1 company; a new generation was cleared every 17.0 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K042051 (Biomet, Inc., 2005) has gone furthest, with 355 descendants of its own.
- 2 other devices also cite its predicate K970501.
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 indications for use of the Biomet hip replacement prosthesis include:
1. Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
2. Rheumatoid arthritis.
3. Correction of functional deformity.
4. Treatment of nonunion, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
5. Revision of previously failed total hip arthroplasty.
These devices are intended for either
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032396 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032396: Ringloc 36MM Line and Modular Femoral Heads.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032396
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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