510(k) · Cleared
ClearedRingloc Constrained Liners
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet Orthopedics, Inc. · KWZ Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer
Cleared on Oct 25, 2002 as substantially equivalent to P960054 (Depuy, A Johnson & Johnson Co., 1997) and 1 other predicate after a 158-day review. Its family tree reaches back 1 generation to 1997. 32 later devices descend from it.
- Decided
- Oct 25, 2002
- Review
- 158 days
- Class
- Class II
- Product code
- KWZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to P960047 (1997). 2 ancestors in all. 32 later devices descend from it, 1 citing it directly.
- Root · 1 generation backP960047 Osteonics Constrained Acetabular InsertHowmedica Osteonics Corp. · 1997
- This deviceK021661 Ringloc Constrained LinersBiomet Orthopedics, Inc. · 2002
- Descendant · cites it directly · 31 of its ownK030923 Epsilon Durasul Constrained Acetabular LinerCenterpulse Orthopedics, Inc. · 2003
- Descendant · 2 generations on · 28 of its ownK071718 Trilogy Longevity Constrained LinerZimmer, Inc. · 2007 · Recalled
- Descendant · 2 generations on · 23 of its ownK092265 Vesafitcup Double Mobility- Highcross Hxuhmwpe LinersMedacta International S.A. · 2010
- Descendant · 3 generations on · 21 of its ownK103721 Mpact Acetabular SystemMedacta International · 2011
- Descendant · 4 generations on · 14 of its ownK122641 Mpact ExtensionMedacta International · 2012
Showing 5 of 32 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 32 · See all- K030923Epsilon Durasul Constrained Acetabular LinerCenterpulse Orthopedics, Inc. · 2003 · cites it directly31descendants
- K071718Trilogy Longevity Constrained LinerZimmer, Inc. · 2007 · 2 generations on28descendants
- K092265Vesafitcup Double Mobility- Highcross Hxuhmwpe LinersMedacta International S.A. · 2010 · 2 generations on23descendants
- K103721Mpact Acetabular SystemMedacta International · 2011 · 3 generations on21descendants
- K122641Mpact ExtensionMedacta International · 2012 · 4 generations on14descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | P960047 | Osteonics Constrained Acetabular Insert | Howmedica Osteonics Corp. | 1997 | — |
| 0 (this device) | K021661 | Ringloc Constrained Liners | Biomet Orthopedics, Inc. | 2002 | — |
| +1 | K030923 | Epsilon Durasul Constrained Acetabular Liner | Centerpulse Orthopedics, Inc. | 2003 | — |
| +2 | K071718 | Trilogy Longevity Constrained Liner | Zimmer, Inc. | 2007 | 1 |
| +2 | K092265 | Vesafitcup Double Mobility- Highcross Hxuhmwpe Liners | Medacta International S.A. | 2010 | — |
| +3 | K103721 | Mpact Acetabular System | Medacta International | 2011 | — |
| +4 | K122641 | Mpact Extension | Medacta International | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2007 | 2 | 0 |
| 2010 | 3 | 0 |
| 2011 | 3 | 0 |
| 2012 | 3 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 5 | 0 |
| 2026 | 3 | 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 KWZ? 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 KWZ device
- #1 K241461 Mpact Constrained Linerscore 15.5 · 10 generations · no Class I recall
- #2 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 |
|---|---|---|---|
| * | P960054 | S-Rom Poly-Dial Constrained LinerSummary page 1…3 10). Device Classification: Class I1 Legally Marketed Device to which Substantially Equivalence is Claimed: Johnson & Johnson S-ROMO Poly-Dial Constrained Liner PMA #P960054 and Osteonics Constrained Acetabular Insert PMA #P960047. Device Description: The RinglocO Constrained Acetabular Liners are pol… | 1997 |
| * | P960047 | Osteonics Constrained Acetabular InsertSummary page 1…Device to which Substantially Equivalence is Claimed: Johnson & Johnson S-ROMO Poly-Dial Constrained Liner PMA #P960054 and Osteonics Constrained Acetabular Insert PMA #P960047. Device Description: The RinglocO Constrained Acetabular Liners are polyethylene liners with a 10" beveled inner edge that, with… | 1997 |
What descends from it? (32)
See all 321 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K030923 | Epsilon Durasul Constrained Acetabular Liner | 2003 | 31 |
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?
How does its category compare?
All KWZ devicesKWZ Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KWZ
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KWZ
104in 2007
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWZ
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWZ
193in 2025
MAUDE reports naming product code KWZ, 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 | 7 | 104 | 0 | 41 |
| 2008 | 1 | — | 0 | 44 |
| 2009 | 1 | — | 0 | 81 |
| 2010 | 1 | — | 8 | 98 |
| 2011 | 1 | — | 0 | 127 |
| 2012 | 1 | — | 1 | 168 |
| 2013 | 0 | — | 0 | 274 |
| 2014 | 0 | — | 0 | 278 |
| 2015 | 0 | — | 0 | 636 |
| 2016 | 1 | — | 0 | 1,180 |
| 2017 | 2 | — | 0 | 477 |
| 2018 | 0 | — | 0 | 283 |
| 2019 | 0 | — | 0 | 532 |
| 2020 | 0 | — | 0 | 288 |
| 2021 | 0 | — | 0 | 216 |
| 2022 | 0 | — | 0 | 158 |
| 2023 | 0 | — | 1 | 164 |
| 2024 | 1 | — | 0 | 145 |
| 2025 | 1 | — | 0 | 193 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
The RinglocB Constrained Liner is indicated for use as a component of a total hip prosthesis in primary and revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intra-operative instability, and for whom all other options to constrained acetabular components have been considered.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021661 · printed Nov 5, 2026
Cite this page
510(k) Report. “K021661: Ringloc Constrained Liners.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K021661
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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